RANDOMIZED PHASE II STUDY OF A WEEKLY 24H-INFUSION OF HIGH-DOSE 5-FU PLUS OR MINUS FOLINIC ACID (HD-FU/FA) VERSUS HD-FU/FA PLUS BIWEEKLY CISPLATIN VERSUS FAMTX (5-FU/ADRIAMYCIN/METHOTREXATE) IN ADVANCED GASTRIC CANCER, AN EORTC/AIO INTERGROUP TRIAL
cisplatin
+ fluorouracil
+ leucovorin calcium
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: January 1, 1996
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the response rates in patients with advanced gastric cancer treated with high-dose fluorouracil (5-FU) with vs without high-dose leucovorin (CF) vs high-dose 5-FU/CF/cisplatin. II. Determine the toxic effects of these regimens in these patients. III. Assess the symptomatic improvement in these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), and disease stage (metastatic vs locally advanced). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive fluorouracil (5-FU) IV over 24 hours weekly for 6 weeks. Arm II: Patients receive leucovorin calcium (CF) IV over 2 hours followed by 5-FU IV over 24 hours weekly for 6 weeks. Arm III: Patients receive CF and 5-FU as in arm II and cisplatin IV over 1 hour on days 1, 15, and 29. Treatment repeats every 7 weeks for a maximum of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 65-135 patients (21-45 per arm) will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.135 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed gastric cancer that is either metastatic or locally advanced and inoperable Bidimensionally measurable disease No CNS metastasis PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within past 12 months No coronary heart disease requiring drug therapy Congestive heart failure or arrhythmia treatable with standard medication allowed Other: No active infection No history of severe mental disorder No other malignancy within past 10 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified