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High-Dose Chemotherapy in Treating Patients With Advanced Stomach Cancer



High-Dose Chemotherapy in Treating Patients With Advanced Stomach Cancer

For Condition: childhood gastrointestinal cancer,stage 3 gastric cancer,stage 4 gastric cancer
Status: No longer recruiting
Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group , Arbeitsgemeinschaft fur Internistische Onkologie
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed gastric cancer that is either metastatic or locally advanced and inoperable - Bidimensionally measurable disease - No CNS metastasis --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 75 and under - Performance status: WHO 0-2 - Life expectancy: At least 3 months - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BernardNordlinger,  Study Chair,  EORTC Gastrointestinal Tract Cancer Cooperative Group

Universitaetsklinik und Strahlenklinik - Essen
ESSEN,  ,  D-45122
Germany
 


Additional Information:
Study ID Numbers:  CDR0000064578;  EORTC-40953
Study Start Date: January 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002722

Other Stage 4 Gastric Cancer Studies:
1. Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

2. High-Dose Chemotherapy in Treating Patients With Advanced Stomach Cancer

3. Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer

4. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

5. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

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