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Status:

COMPLETED

Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

Lead Sponsor:

UNICANCER

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination ch...

Detailed Description

OBJECTIVES: Primary * Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gem...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • No other pancreatic tumor type, including either of the following:
  • Neuroendocrine tumor
  • Acinar cell tumor
  • Metastatic disease
  • Measurable disease in an area not previously irradiated
  • No cerebral metastases or meningeal involvement of the tumor
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 75
  • Performance status
  • WHO 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)
  • Renal
  • Creatinine \< 120 mmol/L
  • Cardiovascular
  • No prior myocardial infarction
  • No prior angina
  • No uncompensated cardiac or coronary insufficiency
  • No symptomatic arrhythmia
  • Gastrointestinal
  • No prior inflammatory bowel disease
  • No prior chronic diarrhea
  • No unresolved symptomatic occlusion or subocclusion of the bowel
  • Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No ongoing active infection
  • No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to study treatment
  • No other serious medical disorder that would preclude study treatment
  • No psychiatric disorder or social or geographic situation that would preclude study participation
  • Not detained or under the guardianship of another person
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy
  • Surgery
  • Not specified
  • Other
  • No concurrent participation in another clinical trial using therapeutic experimental agents

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 30 2010

    Estimated Enrollment :

    342 Patients enrolled

    Trial Details

    Trial ID

    NCT00112658

    Start Date

    November 1 2004

    End Date

    June 30 2010

    Last Update

    March 8 2021

    Active Locations (55)

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

    Page 1 of 14 (55 locations)

    1

    Centre Hospitalier Universitaire d'Amiens

    Amiens, France, 80054

    2

    Hopital Duffaut

    Avignon, France, 84902

    3

    Centre Hospitalier General

    Belfort, France, 90000

    4

    Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, France, 25030