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Status:

UNKNOWN

Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giv...

Detailed Description

OBJECTIVES: Primary * Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the pancreas
  • Metastatic disease
  • Measurable disease (primary tumor or metastasis)
  • At least 1 cm in diameter by spiral CT scan
  • No ampulla of Vater carcinoma or biliary adenocarcinoma
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • Life expectancy more than 12 weeks
  • Absolute neutrophil count \> 1,500/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Alkaline phosphatase \< 5 times normal
  • Bilirubin \< 1.5 times normal
  • Creatinine \< 1.5 times normal
  • No pre-existing neuropathy
  • No unstable or uncontrolled pain
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No serious cardiovascular disease
  • No serious respiratory disease
  • No uncontrolled or persistent hypercalcemia
  • No psychological, familial, social, or geographical condition that would preclude study treatment
  • No other active malignancy
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy or radiotherapy
  • No concurrent corticosteroids

Exclusion

    Key Trial Info

    Start Date :

    September 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    80 Patients enrolled

    Trial Details

    Trial ID

    NCT00268411

    Start Date

    September 1 2004

    Last Update

    May 27 2008

    Active Locations (15)

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

    Page 1 of 4 (15 locations)

    1

    Hopital Duffaut

    Avignon, France, 84902

    2

    C.H.G. Beauvais

    Beauvais, France, 60021

    3

    Hopital Drevon

    Dijon, France, 21000

    4

    Centre Hospitalier de Dreux

    Dreux, France, 28100