Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments docetaxel, epirubicin hydrochloride
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date April 2001
Trial identifier NCT00075465, CDR0000346617, EU-20326, FRE-GERCOR-EPITAXD00-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Objective tumor response rate
time frame:
Time to tumor progression
time frame:

Secondary Outcomes

Measure
Survival without local relapse
time frame:
Overall survival
time frame:
Tolerability
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).