Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00977574
First received: September 12, 2009
Last updated: March 20, 2014
Last verified: December 2013
  Purpose

This randomized phase II trial is studying giving paclitaxel and carboplatin together with bevacizumab to see how well it works compared with giving paclitaxel and carboplatin together with temsirolimus or giving ixabepilone and carboplatin together with bevacizumab in treating patients with stage III, stage IV, or recurrent endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which treatment regimen is most effective in treating patients with endometrial cancer.


Condition Intervention Phase
Endometrial Adenocarcinoma
Endometrial Adenosquamous Cell Carcinoma
Endometrial Clear Cell Carcinoma
Recurrent Endometrial Carcinoma
Stage III Endometrial Carcinoma
Stage IV Endometrial Carcinoma
Drug: paclitaxel
Drug: carboplatin
Biological: bevacizumab
Drug: temsirolimus
Drug: ixabepilone
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC#704865, IND#7921), Paclitaxel/Carboplatin/Temsirolimus (NSC#683864, IND#61010) and Ixabepilone (NSC#710428, IND#59699) / Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Best confirmed response assessed by RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: September 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (paclitaxel, carboplatin, bevacizumab)
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (paclitaxel, carboplatin, temsirolimus)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm III (ixabepilone, carboplatin, bevacizumab)
Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed endometrial carcinoma, including any of the following epithelial cell types:

    • Endometrioid adenocarcinoma
    • Serous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Adenocarcinoma not otherwise specified
    • Mucinous adenocarcinoma
    • Squamous cell carcinoma
    • Transitional cell carcinoma
  • Stage III, IVA-B, or recurrent disease
  • Refractory to curative or established therapy
  • Measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by chest x-ray or ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam
  • Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI
  • No history or evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases
  • Not eligible for a higher priority GOG protocol (any active GOG phase III protocol or rare tumor protocol), if one exists
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelets ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • SGOT and SGPT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Urine protein:creatinine ratio < 1.0 g OR < 1,000 mg by 24-hour urine collection
  • INR and PTT ≤ 1.5 times ULN
  • Fasting cholesterol < 300 mg/dL
  • Fasting triglycerides ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • No other invasive malignancies within the past 3 years, except nonmelanoma skin cancer
  • No serious, non-healing wound, ulcer, or bone fracture, including history of abdominal/pelvic fistula, gastrointestinal perforation, or intraabdominal abscess within the past 3 months

    • No uncorrected underlying lesions that caused the fistula or perforation
  • No active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • No clinically significant cardiovascular disease, including any of the following:

    • Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction or unstable angina within the past 6 months
    • NYHA class II-IV congestive heart failure
    • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), or cardiac arrhythmias requiring anti-arrhythmic medications

      • Atrial fibrillation that is well controlled with anti-arrhythmic medication allowed
    • Peripheral vascular disease ≥ CTCAE grade 2
    • History of cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
    • Aortic aneurysm and/or history of aortic dissection
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No significant traumatic injury within the past 28 days
  • No known history of interstitial pneumonitis
  • No hypoxemia ≥ grade 2 by CTCAE v.3
  • No dyspnea ≥ grade 2 by CTCAE v.3
  • No uncontrolled diabetes or baseline hemoglobin A1C > 8%
  • No peripheral neuropathy > grade 1 by CTCAE v.3
  • At least 4 weeks since prior radiation therapy (RT) for treatment of endometrial carcinoma allowed, including pelvic RT, extended field pelvic/para-aortic RT, and/or intravaginal brachytherapy

    • More than 3 years since prior RT to any portion of the abdominal cavity or pelvis, other than for the treatment of endometrial cancer
    • More than 3 years since prior RT for localized cancer of the breast, head and neck, or skin and no metastatic or recurrent disease
  • At least 1 week since prior hormonal therapy for treatment of endometrial carcinoma
  • More than 28 days since prior and no concurrent major surgical procedure or open biopsy
  • More than 7 days since prior minor surgical procedures, fine-needle aspirates, or core biopsies
  • No prior chemotherapy or target therapy (e.g., bevacizumab or other VEGF pathway targeted therapy, temsirolimus, everolimus, ridaforolimus, sirolimus, or any other PI3K/AKT/mTor pathway targeted therapy), including chemotherapy used for radiation sensitization, for treatment of endometrial carcinoma

    • More than 3 years since prior chemotherapy for any abdominal or pelvic tumor
    • More than 3 years since prior adjuvant chemotherapy for localized breast cancer and no metastatic or recurrent disease
  • No prior cancer treatment that contraindicates this protocol therapy
  • No concurrent treatment with potent CYP3A4 inhibitors and agents that have CYP3A4 induction potential (arms II and III)
  • No concurrent sunitinib malate during temsirolimus treatment (arm II)
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977574

  Hide Study Locations
Locations
United States, Arizona
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
Veterans Administration-San Diego Medical Center
San Diego, California, United States, 92161
University of California At San Diego
San Diego, California, United States, 92103
UCSF-Mount Zion
San Francisco, California, United States, 94115
John Muir Medical Center
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, United States, 80110
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Central Georgia Gynecologic Oncology
Macon, Georgia, United States, 31201
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
Hawaii Minority Based CCOP
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
Pacific Cancer Institute of Maui
Wailuku, Hawaii, United States, 96793
Maui Memorial Medical Center
Wailuku, Hawaii, United States, 96793
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Advocate Sherman Hospital
Elgin, Illinois, United States, 60123
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Indiana
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Indiana University Health La Porte Hospital
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
South Bend Clinic
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
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
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
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, 67901
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
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 - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
University of Kentucky
Lexington, Kentucky, United States, 40536
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maine
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Allegiance Health
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, United States, 39216
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Saint Louis University 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
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65802
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Center of Hope at Renown Medical Center
Reno, Nevada, United States, 89502
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery
Phillipsburg, New Jersey, United States, 08865
Overlook Hospital
Summit, New Jersey, United States, 07902
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
Island Gynecologic Oncology
Brightwaters, New York, United States, 11718
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
New York Hospital Medical Center of Queens
Fresh Meadows, New York, United States, 11365
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, United States, 28816
Cone Health Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Kettering Medical Center
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, United States, 18201
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
South Carolina Oncology Associates PA
Columbia, South Carolina, United States, 29210
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Texas
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Saint Paul Hospital
Dallas, Texas, United States, 75390
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0565
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Vermont
Fletcher Allen Health Care-Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia Oncology Associates-Hampton
Hampton, Virginia, United States, 23666
Virginia Oncology Associates - Lake Wright
Norfolk, Virginia, United States, 23502
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
United States, Washington
PeaceHealth Medical Group PC
Bellingham, Washington, United States, 98226
Harrison Medical Center
Bremerton, Washington, United States, 98310
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States, 98273
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Northwest Hospital
Seattle, Washington, United States, 98133
Olympic Medical Cancer Care Center
Sequim, Washington, United States, 98384
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Rockwood Cancer Treatment Center-Downtown
Spokane, Washington, United States, 99204
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Saint Joseph Medical Center
Tacoma, Washington, United States, 98405
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Aurora Women's Pavilion of Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Investigators
Principal Investigator: Carol Aghajanian Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00977574     History of Changes
Other Study ID Numbers: NCI-2011-01969, NCI-2011-01969, CDR0000654472, GOG-0086P, GOG-0086P, GOG-0086P, U10CA027469
Study First Received: September 12, 2009
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Endometrial Neoplasms
Carcinoma, Adenosquamous
Adenocarcinoma, Clear Cell
Adenomyoepithelioma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Antibodies
Antibodies, Monoclonal
Sirolimus
Everolimus
Epothilone B
Bevacizumab
Carboplatin
Paclitaxel
Epothilones
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014