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Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

Primary Purpose

Recurrent Uterine Corpus Sarcoma, Stage IIIA Uterine Sarcoma, Stage IIIB Uterine Sarcoma

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Docetaxel
Filgrastim
Gemcitabine Hydrochloride
Pegfilgrastim
Placebo
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Uterine Corpus Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have advanced or recurrent uterine leiomyosarcoma with documented disease progression; histologic confirmation of the original primary tumor is required
  • All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must have a GOG Performance Status of 0, 1, or 2
  • Patients must have recovered from effects of recent surgery, radiotherapy or other therapy
  • Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated UTI)
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to first day of study treatment; continuation of hormone replacement therapy is permitted
  • Platelet count greater than or equal to 100,000/mm^3
  • ANC count greater than or equal to 1,500/mm^3
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), per NCI CTCAE Version 4.0 Grade 1
  • Bilirubin within normal range (CTCAE Version 4 Grade 0)
  • SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1)
  • SGOT less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1
  • Alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1
  • Neuropathy (sensory and motor) less than or equal to Grade 1 per the CTCAE Version 4.0.
  • No history of transient ischemic attack (TIA) or stroke or CNS hemorrhage within the past 6 months
  • Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended
  • PT such that international normalized ratio (INR) is =< 1.5 and a PTT =< 1.5 times the institutional upper limit of normal (or an in-therapeutic-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception

Exclusion Criteria:

  • Patients who have received prior cytotoxic chemotherapy for management of uterine sarcoma; patients who have received prior VEGF-pathway targeted agent such as bevacizumab, PTK787, VEGF-trap, or who have received prior treatment with a multi-kinase inhibitor such as sorafenib or sunitinib are not eligible
  • Patients who have had prior therapy with docetaxel or gemcitabine or bevacizumab
  • Patients with a history of other invasive malignancies, with the exceptions of non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels; (necessary use of warfarin or low molecular weight heparin is permitted, provided the INR is maintained in the therapeutic range of approximately 2-3)
  • Patients with major surgery or significant traumatic injury within 28 days prior to study entry
  • Patients with a history of abdominal fistula or perforation within the past 12 months
  • Patients with a current, serious, non-healing wound, ulcer, or bone fracture
  • Patients with history or evidence upon physical examination of CNS disease, including history of primary brain tumor, or any history of brain metastases, or seizures not controlled with standard medical therapy
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies

  • Cardiovascular function; specifically, patient may not have:

    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm Hg in a patient with no history of hypertension; patients with a history of hypertension before enrollment on study are permitted, but such patients must have BP less than or equal to 140/90 mmHg; use of blood pressure medications to achieve and maintain blood pressure control is permitted
    • Myocardial infarction or unstable angina within 6 months of the first date of bevacizumab/placebo therapy
    • New York Heart Association (NYHA) Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < 50% will be excluded from the study
    • Grade 1, Category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise
    • History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab/placebo therapy
    • History of pulmonary embolism or deep vein thrombosis in the past 6 months

  • Patients with, or with anticipation of, invasive procedures as defined below:

    • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab/placebo therapy
    • Major surgical procedure anticipated during the course of the study.
    • Minor surgical procedures (i.e., mediport insertion), fine needle aspirates, or core biopsies within 7 days prior to the first date of bevacizumab/placebo therapy
  • Patients who are pregnant or nursing

Sites / Locations

  • Saint Joseph's Hospital and Medical Center
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • John Muir Medical Center-Concord Campus
  • UC San Diego Moores Cancer Center
  • Kaiser Permanente Los Angeles Medical Center
  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center
  • UCLA / Jonsson Comprehensive Cancer Center
  • Palo Alto Medical Foundation-Gynecologic Oncology
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
  • University of California San Diego
  • UCSF Medical Center-Mount Zion
  • Olive View-University of California Los Angeles Medical Center
  • John Muir Medical Center-Walnut Creek
  • The Medical Center of Aurora
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • Boulder Community Hospital
  • Penrose-Saint Francis Healthcare
  • Porter Adventist Hospital
  • Exempla Saint Joseph Hospital
  • Presbyterian - Saint Lukes Medical Center - Health One
  • Rose Medical Center
  • Colorado Cancer Research Program CCOP
  • Rocky Mountain Gynecologic Oncology PC
  • Swedish Medical Center
  • Saint Mary's Hospital and Regional Medical Center
  • North Colorado Medical Center
  • Saint Anthony Hospital
  • Littleton Adventist Hospital
  • Sky Ridge Medical Center
  • Longmont United Hospital
  • McKee Medical Center
  • Parker Adventist Hospital
  • Saint Mary Corwin Medical Center
  • North Suburban Medical Center
  • SCL Health Lutheran Medical Center
  • Hartford Hospital
  • The Hospital of Central Connecticut
  • Beebe Medical Center
  • Christiana Care Health System-Christiana Hospital
  • Washington Hospital Center
  • Mayo Clinic in Florida
  • Mercy Hospital
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Florida Hospital Orlando
  • UF Cancer Center at Orlando Health
  • Georgia Regents University Medical Center
  • John B Amos Cancer Center
  • Memorial University Medical Center
  • Northwestern University
  • Rush University Medical Center
  • University of Chicago Comprehensive Cancer Center
  • Sudarshan K Sharma MD Limted-Gynecologic Oncology
  • Memorial Medical Center
  • Cadence Cancer Center in Warrenville
  • Elkhart Clinic
  • Michiana Hematology Oncology PC-Elkhart
  • Elkhart General Hospital
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Franciscan Saint Francis Health-Indianapolis
  • Gynecologic Oncology of Indiana
  • Saint Vincent Oncology Center
  • Community Howard Regional Health
  • IU Health La Porte Hospital
  • Michiana Hematology Oncology PC-Mishawaka
  • Saint Joseph Regional Medical Center-Mishawaka
  • Michiana Hematology Oncology PC-Plymouth
  • Memorial Hospital of South Bend
  • Michiana Hematology Oncology PC-South Bend
  • South Bend Clinic
  • Northern Indiana Cancer Research Consortium CCOP
  • Michiana Hematology Oncology PC-Westville
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Cancer Center-West Lakes
  • Iowa Methodist Medical Center
  • Iowa Oncology Research Association CCOP
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates-Laurel
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • University of Iowa/Holden Comprehensive Cancer Center
  • Methodist West Hospital
  • Mercy Medical Center-West Lakes
  • University of Kansas Cancer Center
  • Baptist Health Lexington
  • Norton Hospital Pavilion and Medical Campus
  • The James Graham Brown Cancer Center at University of Louisville
  • University of Maryland/Greenebaum Cancer Center
  • Greater Baltimore Medical Center
  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Walter Reed National Military Medical Center
  • Union Hospital of Cecil County
  • Lahey Hospital and Medical Center
  • Bronson Battle Creek
  • Spectrum Health Big Rapids Hospital
  • Wayne State University/Karmanos Cancer Institute
  • Grand Rapids Clinical Oncology Program
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • Borgess Medical Center
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Mercy Health Mercy Campus
  • Michiana Hematology Oncology PC-Niles
  • Spectrum Health Reed City Hospital
  • Lakeland Hospital
  • Marie Yeager Cancer Center
  • Munson Medical Center
  • Metro Health Hospital
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Fairview-Southdale Hospital
  • Unity Hospital
  • Hutchinson Area Health Care
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • New Ulm Medical Center
  • North Memorial Medical Health Center
  • Mayo Clinic
  • Metro-Minnesota NCI Community Oncology Research Program
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology and Hematology PA-Woodbury
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • Cancer Research for the Ozarks NCORP
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Nebraska Methodist Hospital
  • Women's Cancer Center of Nevada
  • Center of Hope at Renown Medical Center
  • Dartmouth Hitchcock Medical Center
  • Cooper Hospital University Medical Center
  • Morristown Medical Center
  • Virtua Memorial
  • Rutgers Cancer Institute of New Jersey
  • UMDNJ - Robert Wood Johnson University Hospital
  • Overlook Hospital
  • Virtua West Jersey Hospital Voorhees
  • University of New Mexico
  • Southwest Gynecologic Oncology Associates Inc
  • University of New Mexico Cancer Center
  • Memorial Medical Center - Las Cruces
  • Women's Cancer Care Associates LLC
  • State University of New York Downstate Medical Center
  • Mount Sinai Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Stony Brook University Medical Center
  • Carolinas Medical Center/Levine Cancer Institute
  • Novant Health Presbyterian Medical Center
  • Carolinas HealthCare System NorthEast
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • Summa Akron City Hospital/Cooper Cancer Center
  • University of Cincinnati
  • Case Western Reserve University
  • MetroHealth Medical Center
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Cleveland Clinic Foundation
  • Ohio State University Comprehensive Cancer Center
  • Riverside Methodist Hospital
  • Kettering Medical Center
  • Hillcrest Hospital Cancer Center
  • Lake University Ireland Cancer Center
  • University of Oklahoma Health Sciences Center
  • Tulsa Cancer Institute
  • Abington Memorial Hospital
  • Lehigh Valley Hospital-Cedar Crest
  • Geisinger Medical Center
  • Geisinger Medical Center-Cancer Center Hazleton
  • Penn State Milton S Hershey Medical Center
  • Pennsylvania Hospital
  • Fox Chase Cancer Center
  • UPMC-Magee Womens Hospital
  • West Penn Hospital
  • Geisinger Medical Group
  • Reading Hospital
  • Geisinger Wyoming Valley/Henry Cancer Center
  • Women and Infants Hospital
  • Medical University of South Carolina
  • Sanford Cancer Center-Oncology Clinic
  • Avera Cancer Institute
  • Sanford USD Medical Center - Sioux Falls
  • Parkland Memorial Hospital
  • Zale Lipshy University Hospital
  • Clements University Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Baylor All Saints Medical Center at Fort Worth
  • M D Anderson Cancer Center
  • Huntsman Cancer Institute/University of Utah
  • University of Vermont Medical Center
  • University of Wisconsin Hospital and Clinics
  • Cancer Center of Western Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I Gem+Doce+Placebo

Arm II Gem+Doce+Bev

Arm Description

Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

Outcomes

Primary Outcome Measures

Progression-free Survival
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.

Secondary Outcome Measures

Overall Survival
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan. The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.
Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse. Please refer to the adverse event reporting for more detail.
Objective Response Rate as Measured by RECIST 1.1 Criteria
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Full Information

First Posted
November 12, 2009
Last Updated
August 20, 2020
Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01012297
Brief Title
Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
Official Title
A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was targeted to accrue 130 patients, but closed early for futility.
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology

4. Oversight

5. Study Description

Brief Summary
This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine-docetaxel reduces the progression-free survival (PFS) event rate when compared to gemcitabine-docetaxel plus placebo in patients with advanced or recurrent uterine leiomyosarcoma (LMS). SECONDARY OBJECTIVES: I. To determine the objective response rate, as measured by RECIST, of patients treated with fixed-dose rate gemcitabine-docetaxel with bevacizumab, compared with the objective response rate of patients treated with fixed-dose rate gemcitabine-docetaxel with placebo. II. To determine if the addition of bevacizumab to the combination of gemcitabine and docetaxel increases overall survival in patients with advanced or recurrent uterine LMS. III. To determine the toxicity profile of fixed-dose rate gemcitabine-docetaxel with and without bevacizumab in this patient population. IV. To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research. OUTLINE: This is a multicenter study. Patients are stratified according to prior whole-pelvic radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. ARM II: Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Uterine Corpus Sarcoma, Stage IIIA Uterine Sarcoma, Stage IIIB Uterine Sarcoma, Stage IIIC Uterine Sarcoma, Stage IVA Uterine Sarcoma, Stage IVB Uterine Sarcoma, Uterine Corpus Leiomyosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I Gem+Doce+Placebo
Arm Type
Experimental
Arm Description
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Arm Title
Arm II Gem+Doce+Bev
Arm Type
Experimental
Arm Description
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride
Other Intervention Name(s)
dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, filgrastim-SD/01, Neulasta, SD-01, SD-01 sustained duration G-CSF
Intervention Description
Given SC
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan. The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.
Time Frame
Up to 5 years
Title
Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
Description
Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse. Please refer to the adverse event reporting for more detail.
Time Frame
Up to 5 years
Title
Objective Response Rate as Measured by RECIST 1.1 Criteria
Description
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have advanced or recurrent uterine leiomyosarcoma with documented disease progression; histologic confirmation of the original primary tumor is required All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy Patients must have a GOG Performance Status of 0, 1, or 2 Patients must have recovered from effects of recent surgery, radiotherapy or other therapy Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated UTI) Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to first day of study treatment; continuation of hormone replacement therapy is permitted Platelet count greater than or equal to 100,000/mm^3 ANC count greater than or equal to 1,500/mm^3 Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), per NCI CTCAE Version 4.0 Grade 1 Bilirubin within normal range (CTCAE Version 4 Grade 0) SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1) SGOT less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1 Alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1 Neuropathy (sensory and motor) less than or equal to Grade 1 per the CTCAE Version 4.0. No history of transient ischemic attack (TIA) or stroke or CNS hemorrhage within the past 6 months Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended PT such that international normalized ratio (INR) is =< 1.5 and a PTT =< 1.5 times the institutional upper limit of normal (or an in-therapeutic-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) Patients must have signed an approved informed consent and authorization permitting release of personal health information Patients must meet pre-entry requirements Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception Exclusion Criteria: Patients who have received prior cytotoxic chemotherapy for management of uterine sarcoma; patients who have received prior VEGF-pathway targeted agent such as bevacizumab, PTK787, VEGF-trap, or who have received prior treatment with a multi-kinase inhibitor such as sorafenib or sunitinib are not eligible Patients who have had prior therapy with docetaxel or gemcitabine or bevacizumab Patients with a history of other invasive malignancies, with the exceptions of non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels; (necessary use of warfarin or low molecular weight heparin is permitted, provided the INR is maintained in the therapeutic range of approximately 2-3) Patients with major surgery or significant traumatic injury within 28 days prior to study entry Patients with a history of abdominal fistula or perforation within the past 12 months Patients with a current, serious, non-healing wound, ulcer, or bone fracture Patients with history or evidence upon physical examination of CNS disease, including history of primary brain tumor, or any history of brain metastases, or seizures not controlled with standard medical therapy Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies Cardiovascular function; specifically, patient may not have: Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm Hg in a patient with no history of hypertension; patients with a history of hypertension before enrollment on study are permitted, but such patients must have BP less than or equal to 140/90 mmHg; use of blood pressure medications to achieve and maintain blood pressure control is permitted Myocardial infarction or unstable angina within 6 months of the first date of bevacizumab/placebo therapy New York Heart Association (NYHA) Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < 50% will be excluded from the study Grade 1, Category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab/placebo therapy History of pulmonary embolism or deep vein thrombosis in the past 6 months Patients with, or with anticipation of, invasive procedures as defined below: Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab/placebo therapy Major surgical procedure anticipated during the course of the study. Minor surgical procedures (i.e., mediport insertion), fine needle aspirates, or core biopsies within 7 days prior to the first date of bevacizumab/placebo therapy Patients who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martee Hensley
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
John Muir Medical Center-Concord Campus
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Palo Alto Medical Foundation-Gynecologic Oncology
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF Medical Center-Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Olive View-University of California Los Angeles Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
John Muir Medical Center-Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Exempla Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Presbyterian - Saint Lukes Medical Center - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Colorado Cancer Research Program CCOP
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224-2522
Country
United States
Facility Name
Rocky Mountain Gynecologic Oncology PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Saint Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
SCL Health Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Facility Name
Mercy Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
UF Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Georgia Regents University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
John B Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Memorial University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sudarshan K Sharma MD Limted-Gynecologic Oncology
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Cadence Cancer Center in Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Elkhart Clinic
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514-2098
Country
United States
Facility Name
Michiana Hematology Oncology PC-Elkhart
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Indiana University/Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Franciscan Saint Francis Health-Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Gynecologic Oncology of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Saint Vincent Oncology Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Community Howard Regional Health
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
IU Health La Porte Hospital
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Michiana Hematology Oncology PC-Mishawaka
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Saint Joseph Regional Medical Center-Mishawaka
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Michiana Hematology Oncology PC-Plymouth
City
Plymouth
State/Province
Indiana
ZIP/Postal Code
46563
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Michiana Hematology Oncology PC-South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium CCOP
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46628
Country
United States
Facility Name
Michiana Hematology Oncology PC-Westville
City
Westville
State/Province
Indiana
ZIP/Postal Code
46391
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa Oncology Research Association CCOP
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Methodist West Hospital
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-7700
Country
United States
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Norton Hospital Pavilion and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Spectrum Health Big Rapids Hospital
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Mercy Health Mercy Campus
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Michiana Hematology Oncology PC-Niles
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Facility Name
Lakeland Hospital
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Marie Yeager Cancer Center
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview-Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Metro-Minnesota NCI Community Oncology Research Program
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology and Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cancer Research for the Ozarks NCORP
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Center of Hope at Renown Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Virtua Memorial
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
Virtua West Jersey Hospital Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Southwest Gynecologic Oncology Associates Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Memorial Medical Center - Las Cruces
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Women's Cancer Care Associates LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
State University of New York Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Carolinas HealthCare System NorthEast
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Summa Akron City Hospital/Cooper Cancer Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Cancer Center/Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Hillcrest Hospital Cancer Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Lake University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Tulsa Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Medical Center-Cancer Center Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC-Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Geisinger Medical Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sanford Cancer Center-Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Zale Lipshy University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Clements University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor All Saints Medical Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Cancer Center of Western Wisconsin
City
New Richmond
State/Province
Wisconsin
ZIP/Postal Code
54017
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34298376
Citation
Kantidakis G, Litiere S, Neven A, Vinches M, Judson I, Schoffski P, Wardelmann E, Stacchiotti S, D'Ambrosio L, Marreaud S, van der Graaf WTA, Kasper B, Fiocco M, Gelderblom H. Efficacy thresholds for clinical trials with advanced or metastatic leiomyosarcoma patients: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group meta-analysis based on a literature review for soft-tissue sarcomas. Eur J Cancer. 2021 Sep;154:253-268. doi: 10.1016/j.ejca.2021.06.025. Epub 2021 Jul 20.
Results Reference
derived
PubMed Identifier
25713428
Citation
Hensley ML, Miller A, O'Malley DM, Mannel RS, Behbakht K, Bakkum-Gamez JN, Michael H. Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG Oncology/Gynecologic Oncology Group study. J Clin Oncol. 2015 Apr 1;33(10):1180-5. doi: 10.1200/JCO.2014.58.3781. Epub 2015 Feb 23.
Results Reference
derived
Links:
URL
https://nctn-data-archive.nci.nih.gov/
Description
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Learn more about this trial

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

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