Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
Endometrial Cancer
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Community Hospital of Los Gatos
- Chao Family Comprehensive Cancer Center
- University of Colorado Cancer Center
- Walter Reed Army Medical Center
- H. Lee Moffitt Cancer Center and Research Institute
- Rush-Presbyterian-St. Luke's Medical Center
- University of Chicago Cancer Research Center
- Indiana University Cancer Center
- Holden Comprehensive Cancer Center at The University of Iowa
- Albert B. Chandler Medical Center, University of Kentucky
- Tufts University School of Medicine
- University of Massachusetts Memorial Medical Center
- Barbara Ann Karmanos Cancer Institute
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Ellis Fischel Cancer Center - Columbia
- Washington University School of Medicine
- Cooper Hospital/University Medical Center
- Cancer Center of Albany Medical Center
- State University of New York Health Science Center at Brooklyn
- Roswell Park Cancer Institute
- Schneider Children's Hospital at North Shore
- Memorial Sloan-Kettering Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- Lineberger Comprehensive Cancer Center, UNC
- Duke Comprehensive Cancer Center
- Comprehensive Cancer Center at Wake Forest University
- Barrett Cancer Center, The University Hospital
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital - Ohio State University
- University of Oklahoma College of Medicine
- Abington Memorial Hospital
- Milton S. Hershey Medical Center
- University of Pennsylvania Cancer Center
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Medical University of South Carolina
- Brookview Research, Inc.
- Simmons Cancer Center - Dallas
- M.D. Anderson CCOP Research Base
- University of Texas - MD Anderson Cancer Center
- Fletcher Allen Health Care - Medical Center Campus
- Cancer Center at the University of Virginia
- Fred Hutchinson Cancer Research Center
- Tacoma General Hospital
- Tom Baker Cancer Center - Calgary