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Status:

COMPLETED

Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

Lead Sponsor:

UNICANCER

Conditions:

Colorectal Cancer

Eligibility:

All Genders

70-120 years

Phase:

PHASE2

Brief Summary

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

Detailed Description

OBJECTIVES: Primary * Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living scale...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of colorectal adenocarcinoma
  • Metastatic disease
  • Requires first-line therapy for metastatic disease
  • PATIENT CHARACTERISTICS:
  • Age
  • Over 70
  • Performance status
  • Katz's Activities of Daily Living scale \< 6 (≤ 6 for patients ≥ 80 years of age)
  • Life expectancy
  • More than 3 months
  • Hematopoietic
  • Absolute neutrophil count \> 1,500/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Hepatic
  • AST and ALT \< 2 times normal (5 times normal if due to hepatic metastases)
  • Bilirubin \< 2 times normal (5 times normal if due to hepatic metastases)
  • Renal
  • Creatinine clearance \> 30 mL/min
  • Other
  • No clinical neuropathy
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • More than 6 months since prior adjuvant chemotherapy
  • No prior chemotherapy for metastatic disease
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified

Exclusion

    Key Trial Info

    Start Date :

    June 30 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2008

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00104689

    Start Date

    June 30 2003

    End Date

    January 1 2008

    Last Update

    February 21 2021

    Active Locations (9)

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

    Page 1 of 3 (9 locations)

    1

    Centre Regional Francois Baclesse

    Caen, France, 14076

    2

    Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, France, 13273

    3

    Hopital Europeen Georges Pompidou

    Paris, France, 75015

    4

    Polyclinique Francheville

    Périgueux, France, 24004