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Trial record 1 of 1 for:    nrg-gy007
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Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713386
Recruitment Status : Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Brief Summary:
This phase I/II partially randomized 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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid 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 High Grade Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Ovarian Clear Cell Adenocarcinoma Ovarian 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 Drug: Carboplatin Drug: Paclitaxel Drug: Ruxolitinib Drug: Ruxolitinib Phosphate Procedure: Therapeutic Conventional Surgery Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 18, 2016
Estimated Primary Completion Date : September 30, 2020


Arm Intervention/treatment
Active Comparator: Arm I (paclitaxel and carboplatin)
See Detailed Description.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Procedure: Therapeutic Conventional Surgery
Undergo TRS

Experimental: Arm II (ruxolitinib, paclitaxel, and carboplatin)
See Detailed Description.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Drug: Ruxolitinib
Given PO
Other Names:
  • INCB-18424
  • INCB18424
  • Jakafi
  • Oral JAK Inhibitor INCB18424

Drug: Ruxolitinib Phosphate
Given PO
Other Names:
  • INCB-18424 Phosphate
  • Jakafi

Procedure: Therapeutic Conventional Surgery
Undergo TRS




Primary Outcome Measures :
  1. Incidence of hematologic (heme) dose-limiting toxicity (Phase I) [ Time Frame: 42 days (2 cycles) ]
    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).

  2. Progression-free survival (PFS) (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
    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 :
  1. Incidence of adverse events (Phase I) [ Time Frame: Up to 5 years ]
    Will be assessed according to CTEP CTCAE version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018).

  2. 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) [ Time Frame: Up to 6 weeks ]
    Frequencies will be given by the dose-level administered.

  3. 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 ]
  4. Progression-free survival (PFS) (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
    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.

  5. Proportion of patients who have total gross resection (Phase II) [ Time Frame: At the time of surgery ]
    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.

  6. Complete pathological response (Phase II) [ Time Frame: Up to 5 years ]
    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.

  7. Overall survival (OS) (Phase II) [ Time Frame: From randomization until death or date last seen, assessed up to 5 years ]
    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.


Other Outcome Measures:
  1. Change in cancer stem cells (CSC) observed in tissue [ Time Frame: Baseline up to 63 days (3 cycles) ]
    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.

  2. Change in serum C-reactive protein (CRP) [ Time Frame: Baseline up to 63 days (3 cycles) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713386


Locations
Hide Hide 116 study locations
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United States, Arizona
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States, 85338
United States, California
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Delaware
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
United States, Florida
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
Summit Cancer Care-Candler
Savannah, Georgia, United States, 31405
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Carle on Vermilion
Danville, Illinois, United States, 61832
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Indiana
Parkview Regional Medical Center
Fort Wayne, Indiana, United States, 46845
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Kentucky
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States, 40202
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, United States, 40207
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
Women's Cancer Care-Covington
Covington, Louisiana, United States, 70433
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
UMass Memorial Medical Center - Memorial Division
Worcester, Massachusetts, United States, 01605
United States, Michigan
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States, 48183
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
Munson Medical Center
Traverse City, Michigan, United States, 49684
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Fairview Maple Grove Medical Center
Maple Grove, Minnesota, United States, 55369
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08876
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, United States, 87124
United States, New York
Montefiore Medical Center-Einstein Campus
Bronx, New York, United States, 10461
Montefiore Medical Center-Weiler Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Geauga Hospital
Chardon, Ohio, United States, 44024
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Abington Memorial Hospital-Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, United States, 29926-3827
United States, Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
United States, West Virginia
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States, 54482
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert A Burger NRG Oncology
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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02713386    
Other Study ID Numbers: NRG-GY007
NCI-2016-00203 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-GY007
NRG-GY007 ( Other Identifier: NRG Oncology )
NRG-GY007 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Cystadenocarcinoma, Serous
Carcinoma, Endometrioid
Adenocarcinoma, Clear Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Endometrial Neoplasms
Uterine Neoplasms