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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Unknown

Phase 2

Conditions

Gastric Cancer

Treatments

Drug: docetaxel

Drug: epirubicin hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00075465

FRE-GERCOR-EPITAXD00-1

EU-20326

CDR0000346617

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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