Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
NCT ID: NCT00016341
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
INTERVENTIONAL
2001-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV endometrial cancer.
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Detailed Description
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* Compare the progression-free survival and response of patients with stage III or IV or recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs tamoxifen and megestrol.
* Compare the survival of patients treated with these regimens.
* Determine if progesterone receptor status provides information on whether patients are more likely to benefit from chemotherapy.
* Compare the toxicity profiles of these treatment regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified according to progesterone receptor status (negative vs positive). Patients are randomized to 1 of 2 treatment arms.
* Arm I:Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days. Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.
* At time of disease progression, patients cross-over to hormonal therapy as in arm II.
* Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
At time of disease progression, if patients have not previously been enrolled on arm I, patients cross-over to receive chemotherapy as in arm I.
Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6 weeks on cross-over therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42 months.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
cisplatin
doxorubicin hydrochloride
megestrol acetate
paclitaxel
tamoxifen citrate
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed primary stage III or IV or recurrent endometrial cancer
* Poor curative potential with radiotherapy or surgery (alone or in combination)
* Measurable disease
* At least one lesion accurately measured in at least one dimension
* At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, or MRI OR
* At least 10 mm by spiral CT scan
* Disease in a previously irradiated field as sole site of measurable disease allowed only if clear progression after completion of radiotherapy
* Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required
* ER/PR status of measurable tumor optional
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least 100,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
Hepatic:
* Bilirubin normal
* SGPT no greater than 3 times upper limit of normal
Renal:
* Creatinine no greater than 1.6 mg/dL
Cardiovascular:
* LVEF at least 50%
* No third-degree or complete heart block, unless pacemaker is in place
* Other conduction abnormalities or cardiac dysfunction allowed at the investigator's discretion
* No history of deep venous thrombosis
* No uncontrolled angina
Pulmonary:
* No history of pulmonary embolus
Other:
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No concurrent medical illness that would preclude study
* No serious uncontrolled infection
* No serious peripheral neuropathy
* No circumstances that would preclude study compliance
* No sensitivity to E. coli-derived drug preparations
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior biologic therapy allowed
Chemotherapy:
* No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization
Endocrine therapy:
* No prior hormonal therapy for endometrial cancer
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50% of the spine
Surgery:
* See Disease Characteristics
Other:
* Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Jeffrey D. Bloss, MD
Role: STUDY_CHAIR
Washington University Siteman Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Schneider Children's Hospital at North Shore
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
M.D. Anderson CCOP Research Base
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Countries
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Other Identifiers
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GOG-0189
Identifier Type: -
Identifier Source: secondary_id
CDR0000068624
Identifier Type: -
Identifier Source: org_study_id
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