Trials / Completed
CompletedNCT00002722
High-Dose Chemotherapy in Treating Patients With Advanced Stomach Cancer
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving higher doses may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of high-dose chemotherapy in treating patients with advanced stomach cancer.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cisplatin | |
| DRUG | fluorouracil | |
| DRUG | leucovorin calcium |
Timeline
- Start date
- 1996-01-01
- Primary completion
- 1999-08-01
- First posted
- 2004-04-22
- Last updated
- 2012-03-05
Source: ClinicalTrials.gov record NCT00002722. Inclusion in this directory is not an endorsement.