Combination Chemotherapy in Treating Patients With Advanced Stomach Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: docetaxel
* Drug: epirubicin hydrochloride
* Drug: fluorouracil


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed gastric carcinoma not amenable to curative surgery or in relapse after primary surgical resection Locally advanced disease (i.e., measurable locoregional lymph nodes) OR Metastatic disease Bidimensionally measurable disease At least 10 mm X 20 mm by chest x-ray or physical examination At least 10 mm X 10 mm by CT scan No CNS metastasis PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: 0-1 Life expectancy: Greater than 12 weeks Hematopoietic: WBC count at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: BUN normal Creatinine normal Creatinine clearance at least 60 mL/min No severe hypercalcemia Cardiovascular: No unstable cardiac disease requiring treatment No congestive heart failure No angina pectoris even if medically controlled No significant arrhythmias No prior myocardial infarction unless ejection fraction at least 50% by MUGA scan or echocardiogram Neurologic: No prior significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would preclude study No peripheral neuropathy of any origin (alcohol, etc.) greater than grade 1 Other: Fertile patients must use adequate contraception No prior malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix No active uncontrolled infection No other serious illness or medical condition that would preclude study participation No contraindication to corticosteroid use PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior palliative chemotherapy At least 12 months since prior adjuvant or neoadjuvant chemotherapy No prior taxanes Prior fluorouracil allowed in bolus form only Prior cumulative dose of adjuvant or neoadjuvant cisplatin no greater than 300 mg/m2 Endocrine therapy: Prior or concurrent prednisone (or equivalent) allowed for prophylaxis, acute hypersensitivity reactions, or chronic therapy (greater than 6 months) at doses no greater than 20 mg Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No other concurrent experimental drugs No other concurrent anticancer therapies At least 30 days since treatment in prior clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: docetaxel|nan|
|Drug: epirubicin hydrochloride|nan|
|Drug: fluorouracil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer