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Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Primary Purpose

Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
Ruxolitinib Phosphate
Therapeutic Conventional Surgery
Sponsored by
NRG Oncology
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 clinically and radiographically suspected and previously untreated International Federation of Gynecologic and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS) who have undergone biopsies for histologic confirmation
  • Institutional confirmation of Mullerian epithelial adenocarcinoma on core biopsy (not cytology or fine needle aspiration) or laparoscopic biopsy; (for phase II of the study formalin-fixed paraffin-embedded [FFPE] tissue should be available for laboratory analysis); patients with the following histologic epithelial cell types are eligible: high grade serous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or a combination of these
  • 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
  • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination within 28 days prior to registration
    • Radiographic imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease
    • Further protocol-specific assessments
  • Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0, 1, or 2 within 28 days prior to registration
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced by granulocyte colony stimulating factors (within 14 days prior to registration)
  • Platelets greater than or equal to 100,000/mcl (within 14 days prior to registration)
  • Hemoglobin greater than 9.0 mg/dl (transfusions are permitted to achieve baseline hemoglobin level) (within 14 days prior to registration)
  • Estimated creatinine clearance (CrCl) >= 50 mL/min according to the Cockcroft-Gault formula (within 14 days prior to registration)
  • Bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within 14 days prior to registration)
  • Alkaline phosphatase =< 2.5 x ULN (within 14 days prior to registration)
  • Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Ability to swallow and retain oral medication
  • The patient must provide study-specific informed consent prior to study entry
  • BRCA testing results (i.e., comprehensive BRCA1 and BRCA2 sequencing, including assessment of gene rearrangements) must be submitted for all patients enrolled to Amendment 7 and subsequent amendments; BRCA testing results are optional for all patients enrolled prior to Amendment 7; due to the long acceptance of germline BRCA testing through Myriad, Myriad testing reports will be accepted without additional documentation; if testing for germline BRCA is done by other organizations, in addition to the testing report, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) detailing the laboratory results is required; please retain a copy of all reports (positive, variants of unknown significance [VUS], or negative)

Exclusion Criteria:

  • Patients with suspected non-gynecologic malignancy, such as gastrointestinal
  • 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 (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the 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 any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
  • Patients with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcoma
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions
  • Severe, active co-morbidity defined as follows:

    • Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment
    • Known brain or central nervous system metastases or history of uncontrolled seizures
    • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate)
    • Partial or complete gastrointestinal obstruction
  • Patients who are not candidates for major abdominal surgery due to known medical comorbidities
  • Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol
  • Patients who are unwilling to be transfused with blood components
  • Concurrent anticancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy)
  • Receipt of an investigational study drug for any indication within 30 days or 5 half-lives (whichever is longer) prior to day 1 of protocol therapy
  • Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
  • Patients who are pregnant or nursing; the effects of ruxolitinib on the developing human fetus are unknown; for this reason, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP must have a screening negative serum or urine pregnancy test within 14 days of registration; a second pregnancy test must be done within 24 hours prior to the start of the first cycle of study treatment; women must not be breastfeeding

    • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception
    • Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mL
  • Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection or known history of tuberculosis; (This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive)

Sites / Locations

  • CTCA at Western Regional Medical Center
  • Sutter Auburn Faith Hospital
  • UC San Diego Moores Cancer Center
  • UCLA / Jonsson Comprehensive Cancer Center
  • Sutter Roseville Medical Center
  • Sutter Medical Center Sacramento
  • California Pacific Medical Center-Pacific Campus
  • Danbury Hospital
  • Norwalk Hospital
  • Helen F Graham Cancer Center
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • Sarasota Memorial Hospital
  • Northside Hospital
  • Augusta University Medical Center
  • Memorial Health University Medical Center
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Summit Cancer Care-Candler
  • Northwestern University
  • John H Stroger Jr Hospital of Cook County
  • University of Chicago Comprehensive Cancer Center
  • Carle on Vermilion
  • Carle Physician Group-Effingham
  • Northwestern Medicine Lake Forest Hospital
  • Carle Physician Group-Mattoon/Charleston
  • UC Comprehensive Cancer Center at Silver Cross
  • University of Chicago Medicine-Orland Park
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Midwestern Regional Medical Center
  • Parkview Regional Medical Center
  • Saint Vincent Hospital and Health Care Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • Norton Hospital Pavilion and Medical Campus
  • Norton Suburban Hospital and Medical Campus
  • Mary Bird Perkins Cancer Center
  • Woman's Hospital
  • Women's Cancer Care-Covington
  • Ochsner Medical Center Jefferson
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • UMass Memorial Medical Center - Memorial Division
  • Henry Ford Cancer Institute-Downriver
  • Henry Ford Medical Center-Fairlane
  • Henry Ford Hospital
  • Spectrum Health at Butterworth Campus
  • West Michigan Cancer Center
  • Henry Ford Medical Center-Columbus
  • Munson Medical Center
  • Henry Ford West Bloomfield Hospital
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Fairview Southdale Hospital
  • Fairview Clinics and Surgery Center Maple Grove
  • Abbott-Northwestern Hospital
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Barnes-Jewish Hospital
  • Washington University School of Medicine
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Nebraska Methodist Hospital
  • University of Nebraska Medical Center
  • Women's Cancer Center of Nevada
  • Hackensack University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • Robert Wood Johnson University Hospital Somerset
  • University of New Mexico Cancer Center
  • Southwest Gynecologic Oncology Associates Inc
  • Presbyterian Rust Medical Center/Jorgensen Cancer Center
  • Roswell Park Cancer Institute
  • University of Rochester
  • Wake Forest University Health Sciences
  • UHHS-Chagrin Highlands Medical Center
  • Miami Valley Hospital South
  • Geauga Hospital
  • Case Western Reserve University
  • MetroHealth Medical Center
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Cleveland Clinic Foundation
  • Riverside Methodist Hospital
  • The Mark H Zangmeister Center
  • Hillcrest Hospital Cancer Center
  • UHHS-Westlake Medical Center
  • University of Oklahoma Health Sciences Center
  • Legacy Good Samaritan Hospital and Medical Center
  • Legacy Meridian Park Hospital
  • University of Pennsylvania/Abramson Cancer Center
  • Pennsylvania Hospital
  • University of Pittsburgh Cancer Institute (UPCI)
  • Asplundh Cancer Pavilion
  • Women and Infants Hospital
  • South Carolina Cancer Specialists PC
  • Vanderbilt University/Ingram Cancer Center
  • Parkland Memorial Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • University of Virginia Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Seattle Cancer Care Alliance
  • University of Washington Medical Center - Montlake
  • Legacy Salmon Creek Hospital
  • West Virginia University Charleston Division
  • Marshfield Medical Center-EC Cancer Center
  • University of Wisconsin Carbone Cancer Center
  • Marshfield Medical Center-Marshfield
  • Medical College of Wisconsin
  • Marshfield Clinic-Minocqua Center
  • Marshfield Medical Center-Rice Lake
  • Marshfield Clinic Stevens Point Center
  • Marshfield Clinic-Wausau Center
  • Marshfield Medical Center - Weston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (paclitaxel and carboplatin)

Arm II (ruxolitinib, paclitaxel, and carboplatin)

Arm Description

See Detailed Description.

See Detailed Description.

Outcomes

Primary Outcome Measures

Incidence of hematologic (heme) dose-limiting toxicity (Phase I)
Will be assessed according to Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018).
Progression-free survival (PFS) (Phase II)
Will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. A log-rank test utilizing the categorized values of the exploratory laboratory parameters or a Cox proportional hazards (PH) model to estimate of the hazard ratio for progression or death in PFS. If feasible, the PH model will examine the effect of continuous measures.

Secondary Outcome Measures

Incidence of adverse events (Phase I)
Will be assessed according to CTEP CTCAE version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018).
Frequency of patients who could not receive surgery within the defined timeframe for reasons other than non-response, disease progression, or medical contraindications (Phase I)
Frequencies will be given by the dose-level administered.
Number of patients who discontinue ruxolitinib in the first 3 months of maintenance therapy due to toxicity (Phase I)
Progression-free survival (PFS) (Phase II)
Will be assessed according to RECIST 1.1. Subset analyses within categorized, important exploratory laboratory parameters will examine the treatment effect on PFS. The effect of treatment on PFS will be examined within each of these subsets using a log-rank test or a Cox PH model. Interest will center on whether the hazard of PFS changes from one group to another. The impact of the biomarkers on PFS will be assessed using log-rank tests or Cox PH models.
Proportion of patients who have total gross resection (Phase II)
Will be defined as no visible or palpable tumor remaining after completion of surgery. Differences in the proportion who have total gross resection by treatment arm will be examined with Fisher's Exact Test. The results of this analysis will be presented in terms of the odds ratio (maximum-likelihood estimations and confidence intervals). Multivariate logistic modeling will be conducted if feasible.
Complete pathological response (Phase II)
Will be defined as no evidence of disease on radiographic imaging at the time of radiographic tumor measurement. Differences in the proportion who have complete pathological response by treatment arm will be examined with Fisher's Exact Test. Multivariate logistic modeling will be conducted if feasible.
Overall survival (OS) (Phase II)
The effect of treatment on OS will be conducted with the log-rank statistic and characterized with a Cox PH model. The impact of the biomarkers on OS will be assessed using log-rank tests or Cox PH models.

Full Information

First Posted
March 15, 2016
Last Updated
June 1, 2022
Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02713386
Brief Title
Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Phase I/II Study of Ruxolitinib With Front-Line Neoadjuvant and Post-Surgical Therapy in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I/II trial studies the side effects and the best dose of ruxolitinib phosphate when given together with paclitaxel and carboplatin and to see how well they work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Giving ruxolitinib phosphate together with paclitaxel and carboplatin may be a better treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel and carboplatin alone.
Detailed Description
PRIMARY OBJECTIVES: I. Determine whether treatment with ruxolitinib phosphate (ruxolitinib) in combination with conventional neoadjuvant and post-surgical chemotherapy is safe and tolerable in the primary therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. (Phase I) II. Demonstrate whether treatment with ruxolitinib in combination with conventional neoadjuvant and post-surgical chemotherapy results in a prolonged progression-free survival when compared to chemotherapy alone, in primary therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. (Phase II) SECONDARY OBJECTIVES: I. Determine frequency of patients who do not receive surgery within 6 weeks of completing cycle 3 therapy for reasons other than non-response, disease progression, or medical contraindications. (Phase I) II. Determine if continuation of ruxolitinib as maintenance therapy in participants who complete 6 cycles of standard chemotherapy in combination with ruxolitinib and have not experienced unacceptable toxicity or disease progression is safe and tolerable. (Phase I) III. Determine the impact of ruxolitinib in combination with chemotherapy on progression-free survival as a function of proposed exploratory biomarkers - ALDH+ CD133+ (possibly also CD24+ CK19+) co-staining by AQUA immunofluorescence (IF); ratio of tumor expression of CD8:FOXP3 by immunohistochemistry (IHC); and tumor CD3, CD4, TAI-1, HLA class I and II, CD68 expression by IHC in archived tumor tissue, BRCA status, and serum C-reactive protein (CRP) and IL-6 levels in pre-treatment serum. (Phase II) IV. Investigate the prognostic significance of exploratory laboratory parameters in terms of both progression-free survival and overall survival in women receiving conventional chemotherapy alone. (Phase II) V. Determine whether treatment with ruxolitinib in combination with conventional chemotherapy is associated with total gross resection rate at time of interval cytoreductive surgery. (Phase II) VI. Determine whether treatment with ruxolitinib in combination with conventional chemotherapy is associated with complete pathologic response defined at interval cytoreductive surgery. (Phase II) VII. Demonstrate whether treatment with ruxolitinib in combination with conventional chemotherapy results in an improvement in overall survival in primary management of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. (Phase II) OUTLINE: This is a phase I, dose-escalation study of ruxolitinib phosphate, followed by a phase II study. PHASE I PORTION OF STUDY IS COMPLETE (04/06/2018) PHASE I (CYCLES 1-3): Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-21, paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 6 weeks after completion of cycle 3, patients undergo tumor reductive surgery (TRS). PHASE I (CYCLES 4-6): Within 6 weeks of TRS, patients receive ruxolitinib phosphate PO BID on days 1-21, paclitaxel IV over 1 hour on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. If TRS is not performed due to non-response or medical contraindications and criteria for discontinuation of protocol therapy have not been met, patients should resume ruxolitinib phosphate, paclitaxel, and carboplatin within 6 weeks of completing cycle 3 of therapy. MAINTENANCE THERAPY: Within 3 weeks after completion of cycle 6, patients receive ruxolitinib phosphate PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I (CYCLES 1-3): Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 6 weeks after completion of cycle 3, patients undergo TRS. ARM I (CYCLES 4-6): Within 4 weeks of surgery (or within 6 weeks of completion of cycle 3 in patients who do not undergo TRS), patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. ARM II (CYCLES 1-3): Patients receive ruxolitinib phosphate PO BID on days 1-21 and paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 6 weeks after completion of cycle 3, patients undergo TRS. ARM II (CYCLES 4-6): Within 4 weeks of surgery (or within 6 weeks of completion of cycle 3 in patients who do not undergo TRS), patients receive ruxolitinib phosphate PO BID on days 1-21 and paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients in phase I are followed up until resolution of adverse events, and patients in phase II 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 High Grade Serous Adenocarcinoma, FIGO Stage III Ovarian Cancer, FIGO Stage IIIA Ovarian Cancer, FIGO Stage IIIA1 Ovarian Cancer, FIGO Stage IIIA2 Ovarian Cancer, FIGO Stage IIIB Ovarian Cancer, FIGO Stage IIIC Ovarian Cancer, FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Stage III Fallopian Tube Cancer AJCC v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (paclitaxel and carboplatin)
Arm Type
Active Comparator
Arm Description
See Detailed Description.
Arm Title
Arm II (ruxolitinib, paclitaxel, and carboplatin)
Arm Type
Experimental
Arm Description
See Detailed Description.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
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
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Phosphate
Other Intervention Name(s)
INCB-18424 Phosphate, Jakafi
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo TRS
Primary Outcome Measure Information:
Title
Incidence of hematologic (heme) dose-limiting toxicity (Phase I)
Description
Will be assessed according to Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018).
Time Frame
42 days (2 cycles)
Title
Progression-free survival (PFS) (Phase II)
Description
Will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. A log-rank test utilizing the categorized values of the exploratory laboratory parameters or a Cox proportional hazards (PH) model to estimate of the hazard ratio for progression or death in PFS. If feasible, the PH model will examine the effect of continuous measures.
Time Frame
From study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Incidence of adverse events (Phase I)
Description
Will be assessed according to CTEP CTCAE version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018).
Time Frame
Up to 5 years
Title
Frequency of patients who could not receive surgery within the defined timeframe for reasons other than non-response, disease progression, or medical contraindications (Phase I)
Description
Frequencies will be given by the dose-level administered.
Time Frame
Up to 6 weeks
Title
Number of patients who discontinue ruxolitinib in the first 3 months of maintenance therapy due to toxicity (Phase I)
Time Frame
Up to 3 months in the maintenance phase
Title
Progression-free survival (PFS) (Phase II)
Description
Will be assessed according to RECIST 1.1. Subset analyses within categorized, important exploratory laboratory parameters will examine the treatment effect on PFS. The effect of treatment on PFS will be examined within each of these subsets using a log-rank test or a Cox PH model. Interest will center on whether the hazard of PFS changes from one group to another. The impact of the biomarkers on PFS will be assessed using log-rank tests or Cox PH models.
Time Frame
From study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Title
Proportion of patients who have total gross resection (Phase II)
Description
Will be defined as no visible or palpable tumor remaining after completion of surgery. Differences in the proportion who have total gross resection by treatment arm will be examined with Fisher's Exact Test. The results of this analysis will be presented in terms of the odds ratio (maximum-likelihood estimations and confidence intervals). Multivariate logistic modeling will be conducted if feasible.
Time Frame
At the time of surgery
Title
Complete pathological response (Phase II)
Description
Will be defined as no evidence of disease on radiographic imaging at the time of radiographic tumor measurement. Differences in the proportion who have complete pathological response by treatment arm will be examined with Fisher's Exact Test. Multivariate logistic modeling will be conducted if feasible.
Time Frame
Up to 5 years
Title
Overall survival (OS) (Phase II)
Description
The effect of treatment on OS will be conducted with the log-rank statistic and characterized with a Cox PH model. The impact of the biomarkers on OS will be assessed using log-rank tests or Cox PH models.
Time Frame
From randomization until death or date last seen, assessed up to 5 years
Other Pre-specified Outcome Measures:
Title
Change in cancer stem cells (CSC) observed in tissue
Description
Landmark analyses will be conducted to see if changes in CSC are associated with PFS. The predictive value of CSC will be formally examined with a Cox model using an interaction term with treatment. Subset analyses will be conducted as well in the event that a formal analysis fails to reject the null hypothesis.
Time Frame
Baseline up to 63 days (3 cycles)
Title
Change in serum C-reactive protein (CRP)
Description
The impact of baseline values on PFS and OS can be assessed for prognostic and predictive significance with log-rank statistics and Cox models. The impact of changes in CRP values on PFS and OS can be examined with landmark analyses or as time dependent covariates.
Time Frame
Baseline up to 63 days (3 cycles)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have clinically and radiographically suspected and previously untreated International Federation of Gynecologic and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS) who have undergone biopsies for histologic confirmation Institutional confirmation of Mullerian epithelial adenocarcinoma on core biopsy (not cytology or fine needle aspiration) or laparoscopic biopsy; (for phase II of the study formalin-fixed paraffin-embedded [FFPE] tissue should be available for laboratory analysis); patients with the following histologic epithelial cell types are eligible: high grade serous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or a combination of these 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 Appropriate stage for study entry based on the following diagnostic workup: History/physical examination within 28 days prior to registration Radiographic imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease Further protocol-specific assessments Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0, 1, or 2 within 28 days prior to registration Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced by granulocyte colony stimulating factors (within 14 days prior to registration) Platelets greater than or equal to 100,000/mcl (within 14 days prior to registration) Hemoglobin greater than 9.0 mg/dl (transfusions are permitted to achieve baseline hemoglobin level) (within 14 days prior to registration) Estimated creatinine clearance (CrCl) >= 50 mL/min according to the Cockcroft-Gault formula (within 14 days prior to registration) Bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within 14 days prior to registration) Alkaline phosphatase =< 2.5 x ULN (within 14 days prior to registration) Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 Ability to swallow and retain oral medication The patient must provide study-specific informed consent prior to study entry BRCA testing results (i.e., comprehensive BRCA1 and BRCA2 sequencing, including assessment of gene rearrangements) must be submitted for all patients enrolled to Amendment 7 and subsequent amendments; BRCA testing results are optional for all patients enrolled prior to Amendment 7; due to the long acceptance of germline BRCA testing through Myriad, Myriad testing reports will be accepted without additional documentation; if testing for germline BRCA is done by other organizations, in addition to the testing report, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) detailing the laboratory results is required; please retain a copy of all reports (positive, variants of unknown significance [VUS], or negative) Exclusion Criteria: Patients with suspected non-gynecologic malignancy, such as gastrointestinal 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 (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapy Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the 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 any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer Patients with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcoma Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions Severe, active co-morbidity defined as follows: Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment Known brain or central nervous system metastases or history of uncontrolled seizures Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate) Partial or complete gastrointestinal obstruction Patients who are not candidates for major abdominal surgery due to known medical comorbidities Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol Patients who are unwilling to be transfused with blood components Concurrent anticancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy) Receipt of an investigational study drug for any indication within 30 days or 5 half-lives (whichever is longer) prior to day 1 of protocol therapy Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations Patients who are pregnant or nursing; the effects of ruxolitinib on the developing human fetus are unknown; for this reason, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP must have a screening negative serum or urine pregnancy test within 14 days of registration; a second pregnancy test must be done within 24 hours prior to the start of the first cycle of study treatment; women must not be breastfeeding Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mL Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection or known history of tuberculosis; (This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles N Landen
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
CTCA at Western Regional Medical Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Sutter Auburn Faith Hospital
City
Auburn
State/Province
California
ZIP/Postal Code
95602
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
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
California Pacific Medical Center-Pacific Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
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
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
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
Summit Cancer Care-Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John H Stroger Jr Hospital of Cook County
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
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Northwestern Medicine Lake Forest Hospital
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
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
University of Chicago Medicine-Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Midwestern Regional Medical Center
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Parkview Regional Medical Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
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
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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
Norton Suburban Hospital and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States
Facility Name
Women's Cancer Care-Covington
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
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
UMass Memorial Medical Center - Memorial Division
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Henry Ford Cancer Institute-Downriver
City
Brownstown
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Henry Ford Medical Center-Fairlane
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
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
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Henry Ford Medical Center-Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
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
Fairview Clinics and Surgery Center Maple Grove
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
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
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
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
Robert Wood Johnson University Hospital Somerset
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
University of New Mexico Cancer Center
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
Presbyterian Rust Medical Center/Jorgensen Cancer Center
City
Rio Rancho
State/Province
New Mexico
ZIP/Postal Code
87124
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
UHHS-Chagrin Highlands Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Geauga Hospital
City
Chardon
State/Province
Ohio
ZIP/Postal Code
44024
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
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
The Mark H Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Hillcrest Hospital Cancer Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
UHHS-Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
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
Legacy Good Samaritan Hospital and Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Legacy Meridian Park Hospital
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Asplundh Cancer Pavilion
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
South Carolina Cancer Specialists PC
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926-3827
Country
United States
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
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
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
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
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Legacy Salmon Creek Hospital
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
Facility Name
West Virginia University Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Marshfield Clinic Stevens Point Center
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Facility Name
Marshfield Clinic-Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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