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Status:

UNKNOWN

Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabin...

Detailed Description

OBJECTIVES: Primary * Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin. Secon...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed pancreatic adenocarcinoma
  • Locally advanced or metastatic disease
  • Unresectable disease
  • Measurable disease
  • At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
  • No adenocarcinoma of the bile ducts or ampulla of Vater
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 75
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • More than 12 weeks
  • Hematopoietic
  • Absolute neutrophil count greater than 1,500/mm\^3
  • Platelet count greater than 100,000/mm\^3
  • Hepatic
  • Bilirubin less than 1.5 times normal
  • Alkaline phosphatase less than 5 times normal
  • Renal
  • Creatinine less than 1.5 times normal
  • No uncontrolled or persistent hypercalcemia
  • Cardiovascular
  • No serious cardiac failure
  • Pulmonary
  • No serious respiratory failure
  • Other
  • Pain must be stabilized or controlled before initiation of study treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other untreatable malignant tumor
  • No serious psychological, familial, social, or geographical condition that would preclude study participation
  • No neuropathy that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy
  • Endocrine therapy
  • No concurrent corticosteroids except for antiemetic therapy
  • Radiotherapy
  • No prior radiotherapy
  • Surgery
  • Not specified

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00075452

    Start Date

    November 1 2003

    Last Update

    July 24 2008

    Active Locations (38)

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

    Page 1 of 10 (38 locations)

    1

    Centre Paul Papin

    Angers, France, 49036

    2

    C.H.G. Beauvais

    Beauvais, France, 60021

    3

    Hopital Saint Andre

    Bordeaux, France, 33075

    4

    CHU Ambroise Pare

    Boulogne-Billancourt, France, F-92104