Comparison of Combination Chemotherapy Regimens in Treating Patients With Advanced Stomach Cancer
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction beyond the scope of surgical resection Must have measurable disease in either one or two dimensions either radiographically or by physical examination Measurable disease must be documented outside of a prior radiation portal Evaluable disease only not allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No chronic or unstable angina No uncontrolled congestive heart failure No arrhythmia No chronic angina No myocardial infarction in the past 1 year If history of atherosclerotic heart disease, prior cardiac catheterization or thallium stress test must not suggest coronary artery disease Neurology: No symptomatic peripheral neuropathy greater than grade 2 No cerebellar disease No seizure disorder No organic mental syndrome No major psychoaffective disorder Pulmonary: No chronic obstructive pulmonary disease No chronic bronchitis, emphysema, sarcoid, or bronchiectasis Other: No poorly controlled diabetes mellitus No psychiatric illness No active infections, including AIDS, ARC, or HIV positive No history of hypersensitivity to products containing Polysorbate 80 No history of uncontrolled alcohol or drug abuse No uncontrolled hypercalcemia No other prior malignancy within the past 5 years other than nonmelanomatous skin cancer or cervical carcinoma in situ Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy Endocrine therapy: No chronic use of steroids No concurrent hormonal therapy (except birth control pills) Radiotherapy: At least 1 month since prior radiotherapy No concurrent palliative radiotherapy (arm I patients) Surgery: Must have fully recovered from surgery Other: At least 4 weeks since other investigational agents and recovered from all toxic effects No chronic use of aspirin, nonsteroidal antiinflammatory agents, antianginal medications, or extraordinary antihypertensive regimens
Sites / Locations
- CCOP - Colorado Cancer Research Program, Inc.
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Veterans Affairs Medical Center - Chicago (Lakeside)
- CCOP - Illinois Oncology Research Association
- CCOP - Central Illinois
- CCOP - Cedar Rapids Oncology Project
- CCOP - Ochsner
- New England Medical Center Hospital
- CCOP - Kalamazoo
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Veterans Affairs Medical Center - East Orange
- CCOP - Northern New Jersey
- Albert Einstein Comprehensive Cancer Center
- University of Rochester Cancer Center
- Ireland Cancer Center
- CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
- Allegheny University Hospitals- Hahnemann
- University of Pennsylvania Cancer Center
- University of Pittsburgh Cancer Institute
- CCOP - MainLine Health
- Veterans Affairs Medical Center - Madison
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation
- Pretoria Academic Hospital