Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

Detailed Description
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OBJECTIVES: Primary Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy. Secondary Determine the survival without local relapse and overall survival of patients treated with this regimen. Determine the tolerance to this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Official Title
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Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

Conditions
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Gastric Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach Locally advanced or metastatic disease Measurable disease At least 1 unidimensionally measurable target lesion at least 2 cm in diameter No known symptomatic brain metastases No bone metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count at least 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic Bilirubin less than 2 times normal AST and ALT no greater than 2.5 times normal Alkaline phosphatase no greater than 2.5 times normal Renal Creatinine less than 1.6 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular No serious cardiac failure within the past 12 months No myocardial infarction within the past 12 months No cardiac insufficiency No angina Other Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled serious infection No significant brain or psychiatric disorders No intolerance to cortisone or polysorbate 80 No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No other illness or medical condition that would preclude study participation No peripheral neuropathy greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 21 days since prior participation in another clinical study No other concurrent experimental medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response rate |  |  | 
| Time to tumor progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without local relapse |  |  | 
| Overall survival |  |  | 
| Tolerability |  |  | 

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