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


Phase 2
N/A
75 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Hansjochen Wilke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kliniken Essen-Mitte

Authority:

United States: Federal Government

Study ID:

EORTC-40953

NCT ID:

NCT00002722

Start Date:

January 1996

Completion Date:

Related Keywords:

  • Gastric Cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • Stomach Neoplasms

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