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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02713386
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : March 12, 2019
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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Serous Neoplasm High Grade Ovarian Serous Adenocarcinoma Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Primary Peritoneal Serous Adenocarcinoma Stage III Fallopian Tube Cancer AJCC v7 Stage III Ovarian Cancer AJCC v6 and v7 Stage III Primary Peritoneal Cancer AJCC v7 Stage IIIA Fallopian Tube Cancer AJCC v7 Stage IIIA Ovarian Cancer AJCC v6 and v7 Stage IIIA Primary Peritoneal Cancer AJCC v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIB Ovarian Cancer AJCC v6 and v7 Stage IIIB Primary Peritoneal Cancer AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IIIC Ovarian Cancer AJCC v6 and v7 Stage IIIC Primary Peritoneal Cancer AJCC v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7 Drug: Carboplatin Other: Laboratory Biomarker Analysis Drug: Paclitaxel Drug: Ruxolitinib Phosphate Procedure: Therapeutic Conventional Surgery Phase 1 Phase 2

  Show Detailed Description

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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
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Other: Laboratory Biomarker Analysis
Correlative studies

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
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Other: Laboratory Biomarker Analysis
Correlative studies

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

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 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) (Phase I) [ Time Frame: 42 days (2 courses) ]
  2. Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
    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 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) (Phase I) [ Time Frame: Up to 5 years ]
  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) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
    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, defined as no visible or palpable tumor remaining after completion of surgery (Phase II) [ Time Frame: At the time 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, defined as no evidence of disease on radiographic imaging at the time of radiographic tumor measurement (Phase II) [ Time Frame: Up to 5 years ]
    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 courses) ]
    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 courses) ]
    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/1.73 m^2 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

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; 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

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


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Locations
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United States, Florida
Sarasota Memorial Hospital Suspended
Sarasota, Florida, United States, 34239
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Site Public Contact    404-303-3355    ClinicalTrials@northside.com   
Principal Investigator: Guilherme Henrique C. Cantuaria         
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Site Public Contact    706-721-2388    ga_cares@augusta.edu   
Principal Investigator: Sharad A. Ghamande         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Site Public Contact    912-350-7887    clayter1@memorialhealth.com   
Principal Investigator: James J. Burke         
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Howard A. Zaren         
Summit Cancer Care-Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Howard A. Zaren         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Edward J. Tanner         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: John W. Moroney         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Georgina Cheng         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Georgina Cheng         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Georgina Cheng         
University of Chicago Medicine-Orland Park Recruiting
Orland Park, Illinois, United States, 60462
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: John W. Moroney         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Georgina Cheng         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Georgina Cheng         
United States, Indiana
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Public Contact    317-338-2194    research@stvincent.org   
Principal Investigator: Michael J. Callahan         
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Site Public Contact    800-237-1225      
Principal Investigator: David P. Bender         
United States, Kentucky
Norton Hospital Pavilion and Medical Campus Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact    502-629-2500      
Principal Investigator: Mary E. Gordinier         
Norton Suburban Hospital and Medical Campus Recruiting
Louisville, Kentucky, United States, 40207
Contact: Site Public Contact    502-629-3465      
Principal Investigator: Mary E. Gordinier         
United States, Louisiana
Women's Cancer Care-Covington Recruiting
Covington, Louisiana, United States, 70433
Contact: Site Public Contact    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Patricia S. Braly         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Katrina S. Wade         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Suspended
Baltimore, Maryland, United States, 21287
United States, Michigan
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
Fairview Maple Grove Medical Center Recruiting
Maple Grove, Minnesota, United States, 55369
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
Minnesota Oncology Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Jessica A. Thomes Pepin         
United States, Missouri
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@ccadmin.wustl.edu   
Principal Investigator: Premal H. Thaker         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Premal H. Thaker         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-354-5144      
Principal Investigator: Brent J. Tierney         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Public Contact    201-996-2879      
Principal Investigator: Donna M. McNamara         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Site Public Contact    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Carolyn Y. Muller         
Southwest Gynecologic Oncology Associates Inc Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Site Public Contact    505-272-0530    RDraper@nmcca.org   
Principal Investigator: Carolyn Y. Muller         
Presbyterian Rust Medical Center/Jorgensen Cancer Center Recruiting
Rio Rancho, New Mexico, United States, 87124
Contact: Site Public Contact    505-559-6113    WBurman@phs.org   
Principal Investigator: Carolyn Y. Muller         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Shashikant B. Lele         
United States, Ohio
Miami Valley Hospital South Recruiting
Centerville, Ohio, United States, 45459
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Peter G. Rose         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Peter G. Rose         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Site Public Contact    614-566-4475    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: Site Public Contact    614-488-2118    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Peter G. Rose         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Katherine M. Moxley         
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center Recruiting
Portland, Oregon, United States, 97210
Contact: Site Public Contact    800-220-4937    cancer@lhs.org   
Principal Investigator: Colleen C. McCormick         
Legacy Meridian Park Hospital Recruiting
Tualatin, Oregon, United States, 97062
Contact: Site Public Contact    503-413-1742      
Principal Investigator: Colleen C. McCormick         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    800-474-9892      
Principal Investigator: Robert A. Burger         
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site Public Contact    412-647-8073      
Principal Investigator: Alexander B. Olawaiye         
Abington Memorial Hospital-Asplundh Cancer Pavilion Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Site Public Contact    215-481-2402      
Principal Investigator: Mark S. Shahin         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Site Public Contact    401-274-1122      
Principal Investigator: Cara A. Mathews         
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Alaina J. Brown         
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Site Public Contact    214-590-5582    canceranswerline@UTSouthwestern.edu   
Principal Investigator: David S. Miller         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: David S. Miller         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Site Public Contact    434-243-6303    PAS9E@virginia.edu   
Principal Investigator: Charles N. Landen         
United States, Washington
Legacy Salmon Creek Hospital Recruiting
Vancouver, Washington, United States, 98686
Contact: Site Public Contact    503-413-2150      
Principal Investigator: Colleen C. McCormick         
United States, West Virginia
West Virginia University Charleston Division Recruiting
Charleston, West Virginia, United States, 25304
Contact: Site Public Contact    304-388-9944      
Principal Investigator: Steven J. Jubelirer         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Lisa M. Barroilhet         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-805-4380      
Principal Investigator: William H. Bradley         
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     History of Changes
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: March 12, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
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
Endometrial Neoplasms
Uterine Neoplasms
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous