Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer
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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating advanced stomach cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of combination chemotherapy in treating patients who have advanced stomach cancer.
Drug: epirubicin hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Taxotere-Cisplatin-5FU (TCF) Versus Taxotere-Cisplatin (TC) Versus Epirubicin-Cisplatin-5FU (ECF) as Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial|
|Study Start Date:||August 1999|
|Study Completion Date:||July 2003|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
- Compare the efficacy and tolerability of docetaxel, cisplatin, and fluorouracil (TCF) versus docetaxel and cisplatin (TC) versus epirubicin, cisplatin, and fluorouracil (ECF) in patients with advanced gastric carcinoma.
- Compare the time to treatment failure, time to progression, and survival in this patient population treated with these regimens.
- Compare the quality of life during the treatment period and after failure in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, performance status (0 vs 1), and liver involvement (yes vs no). Patients are randomized to one of three treatment arms.
- Arm I: Patients receive epirubicin IV bolus and cisplatin IV over 4 hours on day 1 plus fluorouracil IV continuously on days 1-21.
- Arm II: Patients receive docetaxel IV over 1 hour and cisplatin IV over 4 hours on day 1.
- Arm III: Patients receive docetaxel and cisplatin as in arm II and fluorouracil as in arm I.
Treatment regimen is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before randomization; at day 1 of courses 2, 4, and 6; and one month after treatment failure.
Patients with complete response or partial response are followed monthly for 3 months.
PROJECTED ACCRUAL: Approximately 111 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004873
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Study Chair:||Arnaud Roth, MD||Hopital Cantonal Universitaire de Geneve|