Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

Last updated: February 18, 2021
Sponsor: UNICANCER
Overall Status: Completed

Phase

2

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT00104689
CDR0000416120
EU-20500
FRE-FNCLCC-GERICO-02/0301
  • Ages 70-120
  • All Genders

Study 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.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

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

Study Design

Total Participants: 60
Study Start date:
June 30, 2003
Estimated Completion Date:
January 31, 2008

Study 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, in older patients with metastatic colorectal adenocarcinoma.

Secondary

  • Determine the toxicity of this regimen in these patients.

  • Determine the percentage of patients who receive the first 3 courses of this regimen (at lower doses) and the percentage of patients who receive all 6 courses of this regimen (at both lower and higher doses).

  • Determine efficacy of this regimen, as defined by RECIST criteria, in these patients.

  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter, open-label, nonrandomized study.

Patients receive oral capecitabine* once daily on days 1-14 and oxaliplatin* IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Connect with a study center

  • Centre Regional Francois Baclesse

    Caen, 14076
    France

    Site Not Available

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

    Marseille, 13273
    France

    Site Not Available

  • Hopital Europeen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Polyclinique Francheville

    Perigueux, 24004
    France

    Site Not Available

  • Institut Jean Godinot

    Reims, 51056
    France

    Site Not Available

  • Centre Rene Huguenin

    Saint Cloud, 92210
    France

    Site Not Available

  • C.H. Senlis

    Senlis, 60309
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31052
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, F-94805
    France

    Site Not Available

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