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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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.

Inclusion 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

- 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate

Safety Issue:

No

Principal Investigator

Christophe Louvet, MD, PhD

Investigator Affiliation:

Hopital Saint Antoine

Authority:

United States: Federal Government

Study ID:

CDR0000346617

NCT ID:

NCT00075465

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Gastric Cancer
  • adenocarcinoma of the stomach
  • stage III gastric cancer
  • stage IV gastric cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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