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Status:

UNKNOWN

Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemothe...

Detailed Description

OBJECTIVES: Primary * Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouraci...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed colorectal adenocarcinoma
  • Metastatic, unresectable disease
  • Meets 1 of the following criteria:
  • At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan
  • Evaluable disease
  • Evidence of disease (e.g., ascites or bone metastases) by imaging techniques
  • Progressive disease as defined by 1 of the following criteria:
  • Progressive disease while receiving first-line chemotherapy
  • Recurrent disease within 6 months after completing adjuvant chemotherapy
  • No symptomatic brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 80
  • Performance status
  • WHO 0-2
  • Life expectancy
  • At least 3 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase \< 3 times ULN
  • Renal
  • Not specified
  • Cardiovascular
  • No uncontrolled angina
  • No myocardial infarction within the past 6 months
  • Gastrointestinal
  • No chronic diarrhea grade 2 or greater
  • No unresolved fully or partially obstructed intestine
  • Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other underlying disease or medical condition that would preclude study participation
  • No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix
  • No psychological, social, familial, or geographical condition that would preclude study follow-up
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • See Disease Characteristics
  • No prior irinotecan
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • At least 3 weeks since prior radiotherapy
  • Surgery
  • At least 3 weeks since prior surgery
  • Other
  • No other concurrent clinical trial participation

Exclusion

    Key Trial Info

    Start Date :

    June 1 2002

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00075595

    Start Date

    June 1 2002

    Last Update

    January 6 2009

    Active Locations (15)

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

    Page 1 of 4 (15 locations)

    1

    Hopital Drevon

    Dijon, France, 21000

    2

    Centre Hospital Universitaire Hop Huriez

    Lille, France, 59037

    3

    Clinique Saint Jean

    Lyon, France, 69008

    4

    Hopital Saint Joseph

    Marseille, France, 13008