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Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00104689
First received: March 3, 2005
Last updated: July 23, 2008
Last verified: December 2006
  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 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Locations
France
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
UNICANCER
Investigators
Investigator: Frederic Viret, MD Institut Paoli-Calmettes
  More 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.

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

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

ClinicalTrials.gov processed this record on November 24, 2014