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Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104689
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 4, 2005
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

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.

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine Drug: oxaliplatin Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70
Study Start Date : July 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale

Secondary Outcome Measures :
  1. Toxicity
  2. Percentage of patients who receive the first 3 treatment courses at a lower dose and the percentage of patients who receive all 6 treatment courses at both lower and higher doses
  3. Efficacy as defined in RECIST criteria
  4. Pharmacokinetics

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of colorectal adenocarcinoma

    • Metastatic disease
  • Requires first-line therapy for metastatic disease



  • 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


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3


  • 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)


  • Creatinine clearance > 30 mL/min


  • No clinical neuropathy


Biologic therapy

  • Not specified


  • More than 6 months since prior adjuvant chemotherapy
  • No prior chemotherapy for metastatic disease

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00104689

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Centre Regional Francois Baclesse
Caen, France, 14076
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Hopital Europeen Georges Pompidou
Paris, France, 75015
Polyclinique Francheville
Perigueux, France, 24004
Institut Jean Godinot
Reims, France, 51056
Centre Rene Huguenin
Saint Cloud, France, 92210
C.H. Senlis
Senlis, France, 60309
Institut Claudius Regaud
Toulouse, France, 31052
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
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OverallOfficial: Frederic Viret, MD Institut Paoli-Calmettes
Publications of Results:
Viret F, Bugat R, Ducreux M, et al.: XELOX regimen in elderly patients with metastatic colorectal cancer (MCRC), a FNCLCC French Collaborative Group GERICO 02 phase II study. [Abstract] J Clin Oncol 25 (Suppl 18): A-19513, 708s, 2007.

Layout table for additonal information Identifier: NCT00104689    
Other Study ID Numbers: CDR0000416120
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents