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Status:

UNKNOWN

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

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Gastric Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief 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 t...

Detailed 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 a...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2001

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00075465

    Start Date

    April 1 2001

    Last Update

    July 24 2008

    Active Locations (23)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (23 locations)

    1

    Centre Paul Papin

    Angers, France, 49036

    2

    Centre Hospitalier Victor Dupouy

    Argenteuil, France, 95107

    3

    Centre Hospital General Robert Ballanger

    Aulnay-sous-Bois, France, 93602

    4

    C.H.G. Beauvais

    Beauvais, France, 60021