Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

This study is currently recruiting participants.
Verified December 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01012297
First received: November 12, 2009
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, 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 blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.


Condition Intervention Phase
Recurrent Uterine Sarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Leiomyosarcoma
Other: placebo
Biological: bevacizumab
Drug: gemcitabine hydrochloride
Drug: docetaxel
Biological: filgrastim
Biological: pegfilgrastim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865, IND #7921) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.


Secondary Outcome Measures:
  • Duration of overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.

  • Response as measured by RECIST 1.1 criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by the CTCAE version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) that are considered to be at least possibly attributable to the study treatment will be tabulated by Version 4.0 of CTCAE major category. For the purpose of the final analyses, non-hematologic AEs will be dichotomized by CTCAE Grade 3 or worse and hematologic toxicities will be dichotomized by CTCAE Grade 4 or worse.


Estimated Enrollment: 130
Study Start Date: November 2009
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Other: placebo
Given IV
Other Name: PLCB
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Biological: pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
  • SD-01 sustained duration G-CSF
Experimental: Arm II
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Biological: pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
  • SD-01 sustained duration G-CSF

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine-docetaxel reduces the progression-free survival (PFS) event rate when compared to gemcitabine-docetaxel plus placebo in patients with advanced or recurrent uterine leiomyosarcoma (LMS).

SECONDARY OBJECTIVES:

I. To determine the objective response rate, as measured by RECIST, of patients treated with fixed-dose rate gemcitabine-docetaxel with bevacizumab, compared with the objective response rate of patients treated with fixed-dose rate gemcitabine-docetaxel with placebo.

II. To determine if the addition of bevacizumab to the combination of gemcitabine and docetaxel increases overall survival in patients with advanced or recurrent uterine LMS.

III. To determine the toxicity profile of fixed-dose rate gemcitabine-docetaxel with and without bevacizumab in this patient population.

IV. To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research.

OUTLINE: This is a multicenter study. Patients are stratified according to prior whole-pelvic radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

ARM II: Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

In both arms, courses repeat every 21 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 and then every 6 months for 3 years.

  Eligibility

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

Inclusion Criteria:

  • Patients must have advanced or recurrent uterine leiomyosarcoma with documented disease progression; histologic confirmation of the original primary tumor is required
  • All patients must have measurable disease as defined by 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 CT, 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
  • Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must have a GOG Performance Status of 0, 1, or 2
  • Patients must have recovered from effects of recent surgery, radiotherapy or other therapy
  • Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated UTI)
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to first day of study treatment; continuation of hormone replacement therapy is permitted
  • Platelet count greater than or equal to 100,000/mm^3
  • ANC count greater than or equal to 1,500/mm^3
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), per NCI CTCAE Version 4.0 Grade 1
  • Bilirubin within normal range (CTCAE Version 4 Grade 0)
  • SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1)
  • SGOT less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1
  • Alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1
  • Neuropathy (sensory and motor) less than or equal to Grade 1 per the CTCAE Version 4.0.
  • No history of transient ischemic attack (TIA) or stroke or CNS hemorrhage within the past 6 months
  • Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended
  • PT such that international normalized ratio (INR) is =< 1.5 and a PTT =< 1.5 times the institutional upper limit of normal (or an in-therapeutic-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception

Exclusion Criteria:

  • Patients who have received prior cytotoxic chemotherapy for management of uterine sarcoma; patients who have received prior VEGF-pathway targeted agent such as bevacizumab, PTK787, VEGF-trap, or who have received prior treatment with a multi-kinase inhibitor such as sorafenib or sunitinib are not eligible
  • Patients who have had prior therapy with docetaxel or gemcitabine or bevacizumab
  • Patients with a history of other invasive malignancies, with the exceptions of non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels; (necessary use of warfarin or low molecular weight heparin is permitted, provided the INR is maintained in the therapeutic range of approximately 2-3)
  • Patients with major surgery or significant traumatic injury within 28 days prior to study entry
  • Patients with a history of abdominal fistula or perforation within the past 12 months
  • Patients with a current, serious, non-healing wound, ulcer, or bone fracture
  • Patients with history or evidence upon physical examination of CNS disease, including history of primary brain tumor, or any history of brain metastases, or seizures not controlled with standard medical therapy
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Cardiovascular function; specifically, patient may not have:

    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm Hg in a patient with no history of hypertension; patients with a history of hypertension before enrollment on study are permitted, but such patients must have BP less than or equal to 140/90 mmHg; use of blood pressure medications to achieve and maintain blood pressure control is permitted
    • Myocardial infarction or unstable angina within 6 months of the first date of bevacizumab/placebo therapy
    • New York Heart Association (NYHA) Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < 50% will be excluded from the study
    • Grade 1, Category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise
    • History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab/placebo therapy
    • History of pulmonary embolism or deep vein thrombosis in the past 6 months
  • Patients with, or with anticipation of, invasive procedures as defined below:

    • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab/placebo therapy
    • Major surgical procedure anticipated during the course of the study.
    • Minor surgical procedures (i.e., mediport insertion), fine needle aspirates, or core biopsies within 7 days prior to the first date of bevacizumab/placebo therapy
  • Patients who are pregnant or nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012297

  Hide Study Locations
Locations
United States, Arizona
Saint Joseph's Hospital and Medical Center Completed
Phoenix, Arizona, United States, 85013
United States, California
Providence Saint Joseph Medical Center Completed
Burbank, California, United States, 91505
John Muir Medical Center-Concord Campus Completed
Concord, California, United States, 94520
Kaiser Permanente Medical Care Program - Los Angeles Medical Center &amp; Sunset Hospital Recruiting
Los Angeles, California, United States, 90027
Contact: Scott E. Lentz    626-564-3455      
Principal Investigator: Scott E. Lentz         
University of Southern California Recruiting
Los Angeles, California, United States, 90033-0804
Contact: Huyen Q. Pham    323-865-0451      
Principal Investigator: Huyen Q. Pham         
Jonsson Comprehensive Cancer Center Completed
Los Angeles, California, United States, 90095
Los Angeles County-USC Medical Center Completed
Los Angeles, California, United States, 90033
Kaiser Permanente Los Angeles Medical Center Completed
Los Angeles, California, United States, 90027
Palo Alto Medical Foundation-Gynecologic Oncology Completed
Mountain View, California, United States, 94040
University of California Medical Center At Irvine-Orange Campus Completed
Orange, California, United States, 92868
University of California At San Diego Completed
San Diego, California, United States, 92103
UCSF-Mount Zion Completed
San Francisco, California, United States, 94115
Olive View-University of California Los Angeles Medical Center Completed
Sylmar, California, United States, 91342
John Muir Medical Center Completed
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Completed
Aurora, Colorado, United States, 80045
The Medical Center of Aurora Completed
Aurora, Colorado, United States, 80012
Boulder Community Hospital Completed
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare Completed
Colorado Springs, Colorado, United States, 80907
Colorado Cancer Research Program CCOP Completed
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital Completed
Denver, Colorado, United States, 80218
Saint Anthony Central Hospital Completed
Denver, Colorado, United States, 80204
Porter Adventist Hospital Completed
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One Completed
Denver, Colorado, United States, 80218
Rose Medical Center Completed
Denver, Colorado, United States, 80220
Swedish Medical Center Completed
Englewood, Colorado, United States, 80110
Rocky Mountain Gynecologic Oncology PC Completed
Englewood, Colorado, United States, 80110
Saint Mary's Hospital and Regional Medical Center Completed
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center Completed
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital Completed
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center Completed
Lone Tree, Colorado, United States, 80124
Longmont United Hospital Completed
Longmont, Colorado, United States, 80501
McKee Medical Center Completed
Loveland, Colorado, United States, 80539
Parker Adventist Hospital Completed
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center Completed
Pueblo, Colorado, United States, 81004
North Suburban Medical Center Completed
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center Completed
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Hartford Hospital Completed
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut Completed
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center Completed
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital Completed
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington Hospital Center Completed
Washington, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic in Florida Completed
Jacksonville, Florida, United States, 32224-9980
Mercy Hospital Completed
Miami, Florida, United States, 33133
University of Miami Miller School of Medicine-Sylvester Cancer Center Completed
Miami, Florida, United States, 33136
M D Anderson Cancer Center- Orlando Completed
Orlando, Florida, United States, 32806
Florida Hospital Completed
Orlando, Florida, United States, 32803
United States, Georgia
Georgia Regents University Completed
Augusta, Georgia, United States, 30912
John B Amos Cancer Center Completed
Columbus, Georgia, United States, 31904
Memorial Health University Medical Center Completed
Savannah, Georgia, United States, 31403
United States, Illinois
University of Chicago Comprehensive Cancer Center Completed
Chicago, Illinois, United States, 60637-1470
Northwestern University Completed
Chicago, Illinois, United States, 60611
Rush University Medical Center Completed
Chicago, Illinois, United States, 60612
Hinsdale Hematology Oncology Associates Incorporated Withdrawn
Hinsdale, Illinois, United States, 60521
Sudarshan K Sharma MD Limted-Gynecologic Oncology Completed
Hinsdale, Illinois, United States, 60521
Memorial Medical Center Completed
Springfield, Illinois, United States, 62781-0001
Central DuPage Hospital Cancer Center Completed
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Francis Hospital and Health Centers Withdrawn
Beech Grove, Indiana, United States, 46107
Michiana Hematology Oncology PC-Elkhart Completed
Elkhart, Indiana, United States, 46514
Elkhart General Hospital Completed
Elkhart, Indiana, United States, 46515
Elkhart Clinic Completed
Elkhart, Indiana, United States, 46514-2098
Franciscan St. Francis Health Completed
Indianapolis, Indiana, United States, 46237
Gynecologic Oncology of Indiana Recruiting
Indianapolis, Indiana, United States, 46237
Contact: David H. Moore    317-851-2555      
Principal Investigator: David H. Moore         
Indiana University Medical Center Completed
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center Completed
Indianapolis, Indiana, United States, 46260
Community Howard Regional Health Completed
Kokomo, Indiana, United States, 46904
Indiana University Health La Porte Hospital Completed
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka Completed
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center-Mishawaka Completed
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth Completed
Plymouth, Indiana, United States, 46563
Northern Indiana Cancer Research Consortium Completed
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend Completed
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend Completed
South Bend, Indiana, United States, 46601
South Bend Clinic Completed
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology-PC Westville Completed
Westville, Indiana, United States, 46391
United States, Iowa
Mercy Cancer Center-West Lakes Completed
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-West Des Moines Completed
Clive, Iowa, United States, 50325
Iowa Methodist Medical Center Completed
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP Completed
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines Completed
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates Completed
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital Completed
Des Moines, Iowa, United States, 50316
Mercy Medical Center - Des Moines Completed
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics Completed
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes Completed
West Des Moines, Iowa, United States, 50266
Methodist West Hospital Completed
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
University of Kansas Medical Center Completed
Kansas City, Kansas, United States, 66160
United States, Kentucky
Baptist Health Lexington Completed
Lexington, Kentucky, United States, 40503
Norton Health Care Pavilion - Downtown Completed
Louisville, Kentucky, United States, 40202
The James Graham Brown Cancer Center at University of Louisville Completed
Louisville, Kentucky, United States, 40202
United States, Maryland
Franklin Square Hospital Center Completed
Baltimore, Maryland, United States, 21237
Greater Baltimore Medical Center Completed
Baltimore, Maryland, United States, 21204
Johns Hopkins University Completed
Baltimore, Maryland, United States, 21287-8936
University of Maryland Greenebaum Cancer Center Completed
Baltimore, Maryland, United States, 21201-1595
Walter Reed National Military Medical Center Completed
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County Completed
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Lahey Hospital and Medical Center Completed
Burlington, Massachusetts, United States, 01805
United States, Michigan
Bronson Battle Creek Completed
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center Completed
Big Rapids, Michigan, United States, 49307
Wayne State University Completed
Detroit, Michigan, United States, 48202
Grand Rapids Clinical Oncology Program Completed
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus Completed
Grand Rapids, Michigan, United States, 49503
Saint Mary's Health Care Completed
Grand Rapids, Michigan, United States, 49503
Bronson Methodist Hospital Completed
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center Completed
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center Completed
Kalamazoo, Michigan, United States, 49001
Mercy Health Partners-Mercy Campus Completed
Muskegon, Michigan, United States, 49444
Michiana Hematology Oncology PC-Niles Completed
Niles, Michigan, United States, 49120
Spectrum Health Reed City Hospital Completed
Reed City, Michigan, United States, 49677
Marie Yeager Cancer Center Completed
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital Completed
St. Joseph, Michigan, United States, 49085
Munson Medical Center Completed
Traverse City, Michigan, United States, 49684
Metro Health Hospital Completed
Wyoming, Michigan, United States, 49519
United States, Minnesota
Fairview Ridges Hospital Completed
Burnsville, Minnesota, United States, 55337
Mercy Hospital Completed
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital Completed
Edina, Minnesota, United States, 55435
Unity Hospital Completed
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care Completed
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood Completed
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast Completed
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center Completed
Minneapolis, Minnesota, United States, 55415
Abbott-Northwestern Hospital Completed
Minneapolis, Minnesota, United States, 55407
New Ulm Medical Center Completed
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center Completed
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Completed
Rochester, Minnesota, United States, 55905
Metro-Minnesota CCOP Completed
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park Completed
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Completed
Saint Paul, Minnesota, United States, 55101
United Hospital Completed
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center Completed
Shakopee, Minnesota, United States, 55379
Lakeview Hospital Completed
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center Completed
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital Completed
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury Completed
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center Completed
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School of Medicine Completed
Saint Louis, Missouri, United States, 63110
Cox Medical Center Completed
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Completed
Springfield, Missouri, United States, 65802
Saint John's Hospital Completed
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital Completed
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada Completed
Las Vegas, Nevada, United States, 89169
Center of Hope at Renown Medical Center Completed
Reno, Nevada, United States, 89502
Renown Regional Medical Center Withdrawn
Reno, Nevada, United States, 89502
United States, New Hampshire
Dartmouth Hitchcock Medical Center Completed
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper Hospital University Medical Center Completed
Camden, New Jersey, United States, 08103
Morristown Memorial Hospital Completed
Morristown, New Jersey, United States, 07962
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Completed
Mount Holly, New Jersey, United States, 08060
UMDNJ - Robert Wood Johnson University Hospital Completed
New Brunswick, New Jersey, United States, 08903
Cancer Institute of New Jersey Completed
New Brunswick, New Jersey, United States, 08903
Overlook Hospital Completed
Summit, New Jersey, United States, 07902
Virtua West Jersey Hospital Voorhees Completed
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Southwest Gynecologic Oncology Associates Inc Completed
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center Completed
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center - Las Cruces Completed
Las Cruces, New Mexico, United States, 88011
United States, New York
Women's Cancer Care Associates LLC Completed
Albany, New York, United States, 12208
State University of New York Downstate Medical Center Completed
Brooklyn, New York, United States, 11203
Memorial Sloan Kettering Cancer Center Completed
New York, New York, United States, 10065
Mount Sinai Medical Center Completed
New York, New York, United States, 10029
Stony Brook University Medical Center Completed
Stony Brook, New York, United States, 11794
United States, North Carolina
Presbyterian Hospital Completed
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center Completed
Charlotte, North Carolina, United States, 28203
Carolinas Medical Center - Northeast Completed
Concord, North Carolina, United States, 28025
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences Completed
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital Completed
Akron, Ohio, United States, 44304
University of Cincinnati Completed
Cincinnati, Ohio, United States, 45267
Case Western Reserve University Completed
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center Completed
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital Completed
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation Completed
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Completed
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital Completed
Columbus, Ohio, United States, 43214
Kettering Medical Center Completed
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center Completed
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center Completed
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center Completed
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates-Yale Completed
Tulsa, Oklahoma, United States, 74136-1929
United States, Pennsylvania
Abington Memorial Hospital Completed
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital Completed
Allentown, Pennsylvania, United States, 18105
Geisinger Medical Center Completed
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton Completed
Hazleton, Pennsylvania, United States, 18201
Penn State Milton S Hershey Medical Center Completed
Hershey, Pennsylvania, United States, 17033-0850
Gynecologic Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Martee L. Hensley    212-639-7202      
Principal Investigator: Martee L. Hensley         
Fox Chase Cancer Center Completed
Philadelphia, Pennsylvania, United States, 19111-2497
Pennsylvania Hospital Completed
Philadelphia, Pennsylvania, United States, 19107
Western Pennsylvania Hospital Completed
Pittsburgh, Pennsylvania, United States, 15224-1791
Magee-Womens Hospital of UPMC Completed
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Medical Group Completed
State College, Pennsylvania, United States, 16801
Reading Hospital and Medical Center Completed
West Reading, Pennsylvania, United States, 19612
Geisinger Wyoming Valley Completed
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital Completed
Providence, Rhode Island, United States, 02905
United States, South Carolina
Medical University of South Carolina Completed
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
Sanford Cancer Center-Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
Avera Cancer Institute Completed
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Vanderbilt-Ingram Cancer Center Withdrawn
Nashville, Tennessee, United States, 37232
United States, Texas
Parkland Memorial Hospital Completed
Dallas, Texas, United States, 75235
Zale Lipshy University Hospital Completed
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center Completed
Dallas, Texas, United States, 75390
Saint Paul Hospital Completed
Dallas, Texas, United States, 75390
Baylor All Saints Medical Center at Fort Worth Completed
Fort Worth, Texas, United States, 76104
M D Anderson Cancer Center Completed
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute/University of Utah Completed
Salt Lake City, Utah, United States, 84112
United States, Vermont
Fletcher Allen Health Care-Medical Center Completed
Burlington, Vermont, United States, 05401
United States, Wisconsin
University of Wisconsin Hospital and Clinics Completed
Madison, Wisconsin, United States, 53792
Aurora Saint Luke's Medical Center Withdrawn
Milwaukee, Wisconsin, United States, 53215
Aurora Sinai Medical Center Withdrawn
Milwaukee, Wisconsin, United States, 53233
Cancer Center of Western Wisconsin Completed
New Richmond, Wisconsin, United States, 54017
Aurora Women's Pavilion of Aurora West Allis Medical Center Withdrawn
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Investigators
Principal Investigator: Martee Hensley Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01012297     History of Changes
Other Study ID Numbers: NCI-2010-01738, NCI-2010-01738, CDR0000659024, GOG-0250, GOG-0250, U10CA027469
Study First Received: November 12, 2009
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leiomyosarcoma
Sarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Antibodies
Antibodies, Monoclonal
Gemcitabine
Lenograstim
Docetaxel
Bevacizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Radiation-Sensitizing Agents
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014