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Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive 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: NCT02315430
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial studies how well cabozantinib-s-malate works in treating patients with ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back or is growing, spreading, or getting worse. Cabozantinib-s-malate may stop the growth of tumor cells by blocking the growth of new blood vessels necessary for tumor growth and also by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Fallopian Tube Clear Cell Adenocarcinoma Ovarian Clear Cell Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Drug: Cabozantinib S-malate Other: Laboratory Biomarker Analysis Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the anti-tumor activity of cabozantinib (XL184) (cabozantinib-s-malate) in women with persistent or recurrent clear cell ovarian cancer, based on the proportion of patients who survive progression-free for at least 6 months and the proportion who have objective tumor response (complete or partial).

SECONDARY OBJECTIVES:

I. To determine the nature, frequency and maximum degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 for cabozantinib (XL184).

II. To determine the progression free survival (PFS) and overall survival (OS) for patients with persistent or recurrent clear cell ovarian cancer treated with cabozantinib (XL184).

TERTIARY OBJECTIVES:

I. To examine the expression of phosphatase and tensin homolog gene (PTEN), phosphorylated v-akt murine thymoma viral oncogene homolog 1 (pAKT), cyclin E, and met proto-oncogene (MET) in formalin-fixed, paraffin-embedded tumor.

II. To examine MET amplification (fluorescence in situ hybridization) in tumor specimens and the relationship to response.

OUTLINE:

Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : February 9, 2019
Actual Study Completion Date : February 9, 2019


Arm Intervention/treatment
Experimental: Treatment (cabozantinib-s-malate)
Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib S-malate
Given PO
Other Names:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL184

Other: Laboratory Biomarker Analysis
Optional correlative studies




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months ]
    A modification of the bivariate two-stage design of Sill, et al, which uses the numbers of patients progression-free at 6 months and the number with objective responses to make inferences about the efficacy of the study drug will be used. Will be characterized graphically and using descriptive statistics such as median survival based on Kaplan-Meier estimates.

  2. Complete or partial objective tumor response, evaluated using the RECIST v1.1 [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Incidence of toxicity as assessed by CTCAE v4 [ Time Frame: Up to 5 years ]
    The nature, frequency and maximum degree of toxicity will be determined. Events will be tabulated using maximum grade for each adverse event term regardless of attribution to study drug.

  2. Progression-free survival [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]
    Will be characterized graphically and using descriptive statistics such as median survival based on Kaplan-Meier estimates.

  3. Overall survival [ Time Frame: Time from start of treatment to time of death or the date of last contact, assessed up to 5 years ]
    Will be characterized graphically and using descriptive statistics such as median survival based on Kaplan-Meier estimates.



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.


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

Inclusion Criteria:

  • A retrospective review of all patients entered will be performed to confirm clear cell histology; patients must have recurrent or, progressive clear cell ovarian cancer not solely based on cancer antigen (CA)-125; primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology; recurrence should be biopsy proven unless the tumor is located in an area deemed unsafe to biopsy by the surgeon; if a biopsy can be obtained without significant risk, then biopsy should be obtained
  • If the primary tumor had at least 50% clear cell histomorphology, a biopsy of the recurrent or persistent tumor is not required; the percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report; if slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), biopsy of recurrent or persistent disease is required
  • If slides of the primary tumor are not available for review, a biopsy of the recurrent or persistent tumor is required to confirm at least 50% clear cell histomorphology; the percentage of involvement must be documented in the pathology report or in an addendum to the original report
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • All patients must submit unstained slides of primary or recurrent tumor for translational analysis
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease; platinum sensitive and resistant patients are eligible
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
  • Concomitant use of additional anti-neoplastic agents will not be allowed in this study
  • Patients may not have received previous therapy with a MET inhibitor
  • Patients must not be eligible for a higher priority (e.g.; phase II/III), National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) protocol for the same population if one exists
  • Patients must be recovered from effects of recent surgery (28 days must elapse between surgery and the start of treatment with cabozantinib)
  • Patients must have >= 4 weeks since prior chemotherapy or radiation (>= 6 weeks for nitrosoureas or mitomycin C)
  • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination within 28 days prior to registration
  • The trial is open only to women with recurrent, progressive clear cell carcinoma of the ovary
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky >= 60%) within 28 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Leukocytes >= 3,000/mcL
  • Hemoglobin >= 9 g/dL
  • Serum albumin >= 2.8 g/dL
  • Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.3 x upper limit of normal (ULN)
  • Partial thromboplastin time (PTT) less than or equal to 1.3 x ULN
  • Creatinine less than or equal to 1.5 times the ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • The urine protein: creatinine ratio (UPCR) is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
  • Bilirubin less than or equal to 1.5 ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times the ULN, unless subjects have liver metastasis, in which case both AST and ALT must be less than or equal to 5 times the ULN
  • Lipase less than or equal to 2 x ULN
  • No clinical evidence of pancreatitis
  • Patients must have a normal baseline thyroid stimulating hormone (TSH); a history of hypothyroidism and/or hyperthyroidism is allowed
  • Women of childbearing potential must have a negative pregnancy test at screening; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; post-menopause is defined as amenorrhea >= 12 consecutive months; note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible reason; women should stop breastfeeding while participating in this trial; male partners of women participants should also use medically-acceptable forms of contraception during the study
  • The patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • Human immunodeficiency virus (HIV) positive patients
  • Patients with serious non-healing wound, ulcer, or bone fracture
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study
  • Patients with clinically significant cardiovascular disease; this includes:

    • Poorly controlled hypertension (> 140 mm Hg and > 90 mm Hg for systolic and diastolic blood pressure [BP]) are ineligible
    • Myocardial infarction or unstable angina within 6 months prior to registration; New York Heart Association (NYHA) grade II or greater congestive heart failure
    • Cardiac arrhythmia requiring medication
  • Grade II or greater peripheral vascular disease based on National Cancer Institute (NCI) Common Toxicity Criteria (CTC); e.g. ischemic rest pain, minor tissue loss, and ulceration or gangrene
  • Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible; patients with a history of hypothyroidism are eligible provided they are currently euthyroid
  • Patients who have a major surgical procedure, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
  • Patients must not be eligible for a higher priority NRG clear cell protocol (Gynecologic Oncology Group [GOG]-0283); rare patients ineligible for GOG-0283 may be eligible for this trial without prior treatment on dasatinib therapy (e.g. they have been deemed allergic to dasatinib)
  • Patients who cannot swallow pills

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): NCT02315430


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Locations
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United States, Alaska
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
Alaska Regional Hospital
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States, 71913
United States, California
Kaiser Permanente-Anaheim
Anaheim, California, United States, 92806
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States, 91706
Kaiser Permanente-Bellflower
Bellflower, California, United States, 90706
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Mills-Peninsula Medical Center
Burlingame, California, United States, 94010
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
Sutter Davis Hospital
Davis, California, United States, 95616
Kaiser Permanente-Fontana
Fontana, California, United States, 92335
Kaiser Permanente - Harbor City
Harbor City, California, United States, 90710
Kaiser Permanente-Irvine
Irvine, California, United States, 92618
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Kaiser Permanente-Cadillac
Los Angeles, California, United States, 90034
Memorial Medical Center
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
Sutter Cancer Research Consortium
Novato, California, United States, 94945
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Kaiser Permanente - Panorama City
Panorama City, California, United States, 91402
Kaiser Permanente-Riverside
Riverside, California, United States, 92505
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
Kaiser Permanente-San Diego Mission
San Diego, California, United States, 92108
Kaiser Permanente-San Diego Zion
San Diego, California, United States, 92120
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
Kaiser Permanente-San Marcos
San Marcos, California, United States, 92078
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States, 95065
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States, 94086
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States, 94589
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States, 91367
United States, Florida
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Northside Hospital-Forsyth
Cumming, Georgia, United States, 30041
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States, 30501
United States, Hawaii
Hawaii Oncology Inc-Pali Momi
'Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
'Aiea, Hawaii, United States, 96701
The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii, United States, 96701
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States, 96813
Hawaii Oncology Inc-POB I
Honolulu, Hawaii, United States, 96813
Island Urology
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States, 96817
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, United States, 62902
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Carle on Vermilion
Danville, Illinois, United States, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States, 62226
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Woodland Cancer Care Center
Michigan City, Indiana, United States, 46360
Reid Health
Richmond, Indiana, United States, 47374
United States, Iowa
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
McFarland Clinic PC - Ames
Ames, Iowa, United States, 50010
McFarland Clinic PC-Boone
Boone, Iowa, United States, 50036
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
Greater Regional Medical Center
Creston, Iowa, United States, 50801
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States, 50129
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States, 50158
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Flaget Memorial Hospital
Bardstown, Kentucky, United States, 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, United States, 40701
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States, 41017
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, United States, 40504
Saint Joseph Hospital East
Lexington, Kentucky, United States, 40509
Jewish Hospital
Louisville, Kentucky, United States, 40202
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, United States, 40215
Jewish Hospital Medical Center Northeast
Louisville, Kentucky, United States, 40245
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, United States, 40165
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
United States, Maine
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Hospital Niles
Niles, Michigan, United States, 49120
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
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
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States, 65613
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Cox Cancer Center Branson
Branson, Missouri, United States, 65616
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Capital Region Southwest Campus
Jefferson City, Missouri, United States, 65109
Freeman Health System
Joplin, Missouri, United States, 64804
Mercy Hospital Joplin
Joplin, Missouri, United States, 64804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nebraska
CHI Health Saint Francis
Grand Island, Nebraska, United States, 68803
Heartland Hematology and Oncology
Kearney, Nebraska, United States, 68845
CHI Health Good Samaritan
Kearney, Nebraska, United States, 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Hematology and Oncology Consultants PC
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Midlands Community Hospital
Papillion, Nebraska, United States, 68046
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
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
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
United States, North Carolina
Sampson Radiation Oncology
Clinton, North Carolina, United States, 28328
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States, 28328
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Onslow Memorial Hospital
Jacksonville, North Carolina, United States, 28546
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States, 28546
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States, 27893
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Ohio
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, United States, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States, 45211
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States, 45236
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, United States, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, United States, 45255
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States, 45014
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights, Ohio, United States, 44124
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States, 44060
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Cancer Center
Springfield, Ohio, United States, 45504
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
University Hospitals Sharon Health Center
Wadsworth, Ohio, United States, 44281
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Saint Charles Health System
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States, 97015
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon, Pennsylvania, United States, 15108
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC Jefferson Regional Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15236
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania, United States, 15401
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States, 15301
United States, South Carolina
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29601
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, United States, 37343
Memorial GYN Plus
Ooltewah, Tennessee, United States, 37363
United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
M D Anderson Cancer Center
Houston, Texas, United States, 77030
MD Anderson Regional Care Center-Katy
Houston, Texas, United States, 77094
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States, 77058
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States, 77478
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States, 77384
United States, Washington
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States, 98520
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue, Washington, United States, 98005
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Harrison Medical Center
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States, 98026
Saint Elizabeth Hospital
Enumclaw, Washington, United States, 98022
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Providence Regional Cancer System-Lacey
Lacey, Washington, United States, 98503
Saint Clare Hospital
Lakewood, Washington, United States, 98499
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States, 98107
Kaiser Permanente Washington
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Providence Regional Cancer System-Shelton
Shelton, Washington, United States, 98584
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, United States, 99216
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States, 99204
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, United States, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Providence Regional Cancer System-Yelm
Yelm, Washington, United States, 98597
United States, West Virginia
Monongalia Hospital
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States, 53105
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin, United States, 54937
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States, 54143
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States, 53188
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Big Horn Basin Cancer Center
Cody, Wyoming, United States, 82414
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: John H Farley NRG Oncology

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02315430     History of Changes
Other Study ID Numbers: NCI-2014-02411
NCI-2014-02411 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-GY001 ( Other Identifier: NRG Oncology )
NRG-GY001 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Adenocarcinoma
Adenocarcinoma, Clear Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms