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Status:

TERMINATED

Chemotherapy With or Without Dalteparin in Treating Patients With Metastatic Pancreatic Cancer

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Chemotherapeutic Agent Toxicity

Pancreatic Cancer

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

Brief Summary

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

Detailed Description

OBJECTIVES: Primary * To demonstrate that preventive anticoagulation with dalteparin reduces the number of thromboembolic events. * To determine the number of thromboembolic events occurring with pr...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the pancreas
  • Metastatic disease
  • Not amenable to treatment
  • No localized or locally advanced disease
  • Measurable disease (metastatic or primary tumor) defined as ≥ 2 cm by CT scan or ≥ 1 cm by spiral CT scan or MRI
  • No progressive thrombo-embolic disease
  • No adenocarcinoma of the biliary tract or ampulla of Vater
  • No known CNS metastases
  • PATIENT CHARACTERISTICS:
  • WHO performance status 0-2
  • Life expectancy \> 12 weeks
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Alkaline phosphatase \< 5 times normal
  • Bilirubin \< 1.5 times normal
  • Creatinine \< 1.5 times normal
  • Creatinine clearance \< 30 mL/min
  • Pain controlled or stabilized via analgesic therapy
  • Affiliation with social security system
  • Not pregnant or nursing
  • No controlled or uncontrolled jaundice
  • No contraindication to study drugs
  • No cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
  • No serious cardiac and/or respiratory disease
  • No other cancer in the past 5 years except the following cancers, provided they have been completely resected:
  • Skin cancer
  • Localized melanoma
  • Carcinoma in situ of the cervix
  • No history of thrombophilia
  • No history of heparin-induced thrombocytopenia
  • No uncontrolled or persistent hypercalcemia
  • No psychological, familial, social, and/or geographical condition that precludes participation in the study
  • PRIOR CONCURRENT THERAPY:
  • No prior hematologic therapy for metastatic disease
  • No prior abdominal radiotherapy
  • No concurrent corticosteroids as anti-emetic therapy
  • No other concurrent anticoagulation

Exclusion

    Key Trial Info

    Start Date :

    October 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2012

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT00662688

    Start Date

    October 1 2007

    End Date

    December 1 2012

    Last Update

    March 13 2013

    Active Locations (6)

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

    Page 1 of 2 (6 locations)

    1

    Centre Hospitalier de Meaux

    Meaux, France, 77104

    2

    Centre Hospitalier Intercommunal Le Raincy - Montfermeil

    Montfermeil, France, 93370

    3

    Hopital Bichat - Claude Bernard

    Paris, France, 75018

    4

    Hopital Saint Antoine

    Paris, France, 75571