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Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Primary Purpose

Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Elesclomol Sodium
Paclitaxel
Sponsored by
GOG Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Clear Cell Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report

    • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (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 computed tomography (CT), magnetic resonance imaging (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
  • Patients 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 not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population
  • Patients must have a GOG performance status of 0, 1, or 2
  • Patients must have baseline lactate dehydrogenase (LDH) levels =< 0.8 x upper limit of normal (ULN)
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy

    • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
    • Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
  • Prior therapy

    • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment
    • Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens; (Note: optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy; non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a phase II trial)
    • Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
    • Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
    • Patients must be considered platinum resistant or refractory according to standard GOG criteria, i.e., have had a treatment-free interval following platinum of less than 6 months, or have progressed during platinum-based therapy
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • 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 study entry and be practicing an effective form of contraception
  • Cautions and prohibited medications/treatments

    • Since elesclomol is a substrate for cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9), cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6), cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) and an inducer of CYP3A4, cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), cytochrome P450 family 2, subfamily A, polypeptide 6 (CYP2A6), and cytochrome P450 family 2, subfamily E, polypeptide 1 (CY2E1), it is recommended that the following be used with caution: sensitive substrates of CYP3A4, CYP1A2, and CY2E1, and strong inhibitors and inducers of CYP2C9, CYP2D6, CYP2C19, and CYP3A4

Exclusion Criteria:

  • Patients who have had prior therapy with elesclomol or prior second-line cytotoxic chemotherapy
  • Patients who have received radiation to more than 25% of marrow-bearing areas
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients who are pregnant or breastfeeding

Sites / Locations

  • Saint Joseph's Hospital and Medical Center
  • John Muir Medical Center-Concord Campus
  • UC San Diego Moores Cancer Center
  • University of California San Diego
  • John Muir Medical Center-Walnut Creek
  • University of Colorado Hospital
  • University of Connecticut
  • Hartford Hospital
  • Smilow Cancer Hospital Care Center at Saint Francis
  • The Hospital of Central Connecticut
  • Beebe Medical Center
  • Christiana Care Health System-Christiana Hospital
  • Piedmont Hospital
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Saint Alphonsus Cancer Care Center-Boise
  • Rush University Medical Center
  • University of Chicago Comprehensive Cancer Center
  • Cancer Care Specialists of Illinois - Decatur
  • Decatur Memorial Hospital
  • Crossroads Cancer Center
  • Sudarshan K Sharma MD Limited-Gynecologic Oncology
  • UC Comprehensive Cancer Center at Silver Cross
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Saint Vincent Hospital and Health Care Center
  • McFarland Clinic PC - Ames
  • Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates-Laurel
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas - Newton
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Ascension Via Christi Hospitals Wichita
  • Cancer Center of Kansas - Wichita
  • Wichita NCI Community Oncology Research Program
  • Cancer Center of Kansas - Winfield
  • University of Kentucky/Markey Cancer Center
  • Woman's Hospital
  • Greater Baltimore Medical Center
  • Christiana Care - Union Hospital
  • Michigan Cancer Research Consortium NCORP
  • Saint Joseph Mercy Hospital
  • Beaumont Hospital - Dearborn
  • Ascension Saint John Hospital
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Allegiance Health
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Borgess Medical Center
  • Sparrow Hospital
  • Saint Mary Mercy Hospital
  • Saint Joseph Mercy Oakland
  • Lake Huron Medical Center
  • Ascension Saint Mary's Hospital
  • Saint John Macomb-Oakland Hospital
  • University of Mississippi Medical Center
  • Saint Francis Medical Center
  • Washington University School of Medicine
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Women's Cancer Center of Nevada
  • Cooper Hospital University Medical Center
  • MD Anderson Cancer Center at Cooper-Voorhees
  • Stony Brook University Medical Center
  • Randolph Hospital
  • Cone Health Cancer Center at Alamance Regional
  • Novant Health Presbyterian Medical Center
  • Duke University Medical Center
  • Cone Health Cancer Center
  • Hendersonville Hematology and Oncology at Pardee
  • Margaret R Pardee Memorial Hospital
  • Novant Health Cancer Institute - Kernersville
  • Cone Heath Cancer Center at Mebane
  • Novant Health Cancer Institute - Mount Airy
  • Annie Penn Memorial Hospital
  • Novant Health Cancer Institute - Thomasville
  • Novant Health Cancer Institute - Wilkesboro
  • Novant Health Forsyth Medical Center
  • Novant Health Oncology Specialists
  • Winston-Salem Health Care
  • Wake Forest University Health Sciences
  • Summa Health System - Akron Campus
  • Cleveland Clinic Akron General
  • Strecker Cancer Center-Belpre
  • Adena Regional Medical Center
  • University of Cincinnati Cancer Center-UC Medical Center
  • Case Western Reserve University
  • MetroHealth Medical Center
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Cleveland Clinic Foundation
  • Columbus Oncology and Hematology Associates Inc
  • Riverside Methodist Hospital
  • Columbus NCI Community Oncology Research Program
  • Grant Medical Center
  • The Mark H Zangmeister Center
  • Mount Carmel Health Center West
  • Doctors Hospital
  • Grandview Hospital
  • Delaware Health Center-Grady Cancer Center
  • Delaware Radiation Oncology
  • Grady Memorial Hospital
  • Kettering Medical Center
  • Fairfield Medical Center
  • Lancaster Radiation Oncology
  • Marietta Memorial Hospital
  • Hillcrest Hospital Cancer Center
  • UH Seidman Cancer Center at Lake Health Mentor Campus
  • Knox Community Hospital
  • Licking Memorial Hospital
  • Newark Radiation Oncology
  • Southern Ohio Medical Center
  • Springfield Regional Medical Center
  • University of Toledo
  • Saint Ann's Hospital
  • Genesis Healthcare System Cancer Care Center
  • University of Oklahoma Health Sciences Center
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Jefferson Abington Hospital
  • Bryn Mawr Hospital
  • Paoli Memorial Hospital
  • Lankenau Medical Center
  • Women and Infants Hospital
  • Black Hills Obstetrics and Gynecology
  • Rapid City Regional Hospital
  • Avera Cancer Institute
  • Wellmont Bristol Regional Medical Center
  • Wellmont Medical Associates Oncology and Hematology-Johnson City
  • Regional Cancer Center at Indian Path Community Hospital
  • Wellmont Holston Valley Hospital and Medical Center
  • Lyndon Baines Johnson General Hospital
  • M D Anderson Cancer Center
  • University of Vermont Medical Center
  • University of Virginia Cancer Center
  • Southwest VA Regional Cancer Center
  • Virginia Commonwealth University/Massey Cancer Center
  • Carilion Clinic Gynecological Oncology
  • Pacific Gynecology Specialists
  • Fred Hutchinson Cancer Research Center
  • Seattle Cancer Care Alliance
  • Swedish Medical Center-First Hill
  • University of Washington Medical Center - Northwest
  • University of Washington Medical Center - Montlake
  • Cancer Care Northwest - Spokane South
  • Providence Saint Mary Regional Cancer Center
  • Green Bay Oncology at Saint Vincent Hospital
  • Saint Vincent Hospital Cancer Center Green Bay
  • Green Bay Oncology Limited at Saint Mary's Hospital
  • University of Wisconsin Hospital and Clinics
  • Holy Family Memorial Hospital
  • Bay Area Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel, elesclomol sodium)

Arm Description

Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.

Outcomes

Primary Outcome Measures

Proportion of Participants With Objective Response
Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as 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.
Duration of Objective Response
Duration of objective response (months)
Number of Participants Who Experienced at Least One Adverse Event
The frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment.
The Number of Participants Who Experienced at Least One Grade 3 Adverse Event
The number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.

Secondary Outcome Measures

Progression-free Survival (Median)
Progression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival (Median)
Overall survival (median, in months) will be analyzed by Kaplan-Meier analysis.

Full Information

First Posted
April 24, 2009
Last Updated
September 28, 2021
Sponsor
GOG Foundation
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00888615
Brief Title
Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Official Title
A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 13, 2010 (Actual)
Primary Completion Date
September 1, 2011 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by making tumor cells more sensitive to the drug.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the antitumor activity of elesclomol (elesclomol sodium) and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer primarily through the frequency of objective tumor responses. II. To determine the nature and degree of toxicity of elesclomol and paclitaxel in this cohort of patients. SECONDARY OBJECTIVES: I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel. OUTLINE: Patients receive paclitaxel intravenously (IV) over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study. 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
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Tumor, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel, elesclomol sodium)
Arm Type
Experimental
Arm Description
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Intervention Type
Drug
Intervention Name(s)
Elesclomol Sodium
Other Intervention Name(s)
STA-4783
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of Participants With Objective Response
Description
Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as 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
Title
Duration of Objective Response
Description
Duration of objective response (months)
Time Frame
Up to 5 years
Title
Number of Participants Who Experienced at Least One Adverse Event
Description
The frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment.
Time Frame
Up to 5 years
Title
The Number of Participants Who Experienced at Least One Grade 3 Adverse Event
Description
The number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free Survival (Median)
Description
Progression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Title
Overall Survival (Median)
Description
Overall survival (median, in months) will be analyzed by Kaplan-Meier analysis.
Time Frame
From start of treatment to time of death or the date of last contact, assessed 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 recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.) All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (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 computed tomography (CT), magnetic resonance imaging (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 Patients 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 not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population Patients must have a GOG performance status of 0, 1, or 2 Patients must have baseline lactate dehydrogenase (LDH) levels =< 0.8 x upper limit of normal (ULN) Recovery from effects of recent surgery, radiotherapy, or chemotherapy Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration Prior therapy Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens; (Note: optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy; non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a phase II trial) Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction Patients must be considered platinum resistant or refractory according to standard GOG criteria, i.e., have had a treatment-free interval following platinum of less than 6 months, or have progressed during platinum-based therapy Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl Platelets greater than or equal to 100,000/mcl Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) Bilirubin less than or equal to 1.5 x ULN Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 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 study entry and be practicing an effective form of contraception Cautions and prohibited medications/treatments Since elesclomol is a substrate for cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9), cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6), cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) and an inducer of CYP3A4, cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), cytochrome P450 family 2, subfamily A, polypeptide 6 (CYP2A6), and cytochrome P450 family 2, subfamily E, polypeptide 1 (CY2E1), it is recommended that the following be used with caution: sensitive substrates of CYP3A4, CYP1A2, and CY2E1, and strong inhibitors and inducers of CYP2C9, CYP2D6, CYP2C19, and CYP3A4 Exclusion Criteria: Patients who have had prior therapy with elesclomol or prior second-line cytotoxic chemotherapy Patients who have received radiation to more than 25% of marrow-bearing areas Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease Patients who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley J Monk
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
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
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
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
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
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
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Sudarshan K Sharma MD Limited-Gynecologic Oncology
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
UC Comprehensive Cancer Center at Silver Cross
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
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
Saint Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
McFarland Clinic PC - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Iowa Methodist Medical Center
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
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Ascension Via Christi Hospitals Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wichita NCI Community Oncology Research Program
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Christiana Care - Union Hospital
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Michigan Cancer Research Consortium NCORP
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Beaumont Hospital - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
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
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Saint Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Lake Huron Medical Center
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Ascension Saint Mary's Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
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
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
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
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
MD Anderson Cancer Center at Cooper-Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
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
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Cone Health Cancer Center at Alamance Regional
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
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
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cone Health Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Hendersonville Hematology and Oncology at Pardee
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Margaret R Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Novant Health Cancer Institute - Kernersville
City
Kernersville
State/Province
North Carolina
ZIP/Postal Code
27284
Country
United States
Facility Name
Cone Heath Cancer Center at Mebane
City
Mebane
State/Province
North Carolina
ZIP/Postal Code
27302
Country
United States
Facility Name
Novant Health Cancer Institute - Mount Airy
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Annie Penn Memorial Hospital
City
Reidsville
State/Province
North Carolina
ZIP/Postal Code
27320
Country
United States
Facility Name
Novant Health Cancer Institute - Thomasville
City
Thomasville
State/Province
North Carolina
ZIP/Postal Code
27360
Country
United States
Facility Name
Novant Health Cancer Institute - Wilkesboro
City
Wilkesboro
State/Province
North Carolina
ZIP/Postal Code
28659
Country
United States
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Winston-Salem Health Care
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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 Health System - Akron Campus
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Cleveland Clinic Akron General
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Strecker Cancer Center-Belpre
City
Belpre
State/Province
Ohio
ZIP/Postal Code
45714
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
University of Cincinnati Cancer Center-UC Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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
Columbus Oncology and Hematology Associates Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Columbus NCI Community Oncology Research Program
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
The Mark H Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Mount Carmel Health Center West
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Delaware Health Center-Grady Cancer Center
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Delaware Radiation Oncology
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Lancaster Radiation Oncology
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Hillcrest Hospital Cancer Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
UH Seidman Cancer Center at Lake Health Mentor Campus
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Knox Community Hospital
City
Mount Vernon
State/Province
Ohio
ZIP/Postal Code
43050
Country
United States
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Newark Radiation Oncology
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Southern Ohio Medical Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Facility Name
Springfield Regional Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Saint Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Genesis Healthcare System Cancer Care Center
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
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
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Jefferson Abington Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Black Hills Obstetrics and Gynecology
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Wellmont Bristol Regional Medical Center
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Wellmont Medical Associates Oncology and Hematology-Johnson City
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Regional Cancer Center at Indian Path Community Hospital
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Wellmont Holston Valley Hospital and Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Lyndon Baines Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026-1967
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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 Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Southwest VA Regional Cancer Center
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Clinic Gynecological Oncology
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
University of Washington Medical Center - Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Green Bay Oncology at Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology Limited at Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
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
Holy Family Memorial Hospital
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221
Country
United States
Facility Name
Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30309721
Citation
Monk BJ, Kauderer JT, Moxley KM, Bonebrake AJ, Dewdney SB, Secord AA, Ueland FR, Johnston CM, Aghajanian C. A phase II evaluation of elesclomol sodium and weekly paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer: An NRG oncology/gynecologic oncology group study. Gynecol Oncol. 2018 Dec;151(3):422-427. doi: 10.1016/j.ygyno.2018.10.001. Epub 2018 Oct 8.
Results Reference
derived

Learn more about this trial

Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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