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Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: March 3, 2005   Last Updated: July 23, 2008   History of Changes
Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00104689
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: capecitabine
Drug: oxaliplatin
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Oxaliplatin Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]
  • Efficacy as defined in RECIST criteria [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2003
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, 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104689

Locations
France
C.H. Senlis
Senlis, France, 60309
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Rene Huguenin
Saint Cloud, France, 92210
Hopital Europeen Georges Pompidou
Paris, France, 75015
Polyclinique Francheville
Perigueux, France, 24004
Institut Gustave Roussy
Villejuif, France, F-94805
Institut Jean Godinot
Reims, France, 51056
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Institut Claudius Regaud
Toulouse, France, 31052
Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer
Investigators
Investigator: Frederic Viret, MD Institut Paoli-Calmettes
  More Information

Additional Information:
Publications:
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.

Study ID Numbers: CDR0000416120, FRE-FNCLCC-GERICO-02/0301, EU-20500
Study First Received: March 3, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00104689     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Oxaliplatin
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Carcinoma
Oxaliplatin
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009