Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 75 Other FRE-GERCOR-EPITAXD00-1 EU-20326, NCT00075465

Objectives

Primary

1. 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

1. Determine the survival without local relapse and overall survival of patients treated with this regimen.
2. Determine the tolerance to this regimen in these patients.

Entry Criteria

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

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

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/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

A total of 39 patients will be accrued for this study.

Outcomes

Objective tumor response rate
Time to tumor progression

Survival without local relapse
Overall survival
Tolerability

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.

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Christophe Louvet, MD, PhD, Study coordinator		Ph: 33-1-49-282-343 Email: christophe.louvet@sat.aphp.fr

Registry Information
Official Title		Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients with Advanced or Metastatic Adenocarcinoma of the Stomach
Trial Start Date		2001-04-01
Registered in ClinicalTrials.gov		NCT00075465
Date Submitted to PDQ		2003-11-17
Information Last Verified		2007-07-31

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