- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00104689
Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14076
- Centre Regional Francois Baclesse
-
Marseille, France, 13273
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
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Paris, France, 75015
- Hôpital Européen Georges Pompidou
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Perigueux, France, 24004
- Polyclinique Francheville
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Reims, France, 51056
- Institut Jean Godinot
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Saint Cloud, France, 92210
- Centre René Huguenin
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Senlis, France, 60309
- C.H. Senlis
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Toulouse, France, 31052
- Institut Claudius Regaud
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Villejuif, France, F-94805
- Institut Gustave Roussy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Capecitabine + Oxaliplatin
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Pharmacokinetics
|
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
|
Efficacy as defined in RECIST criteria
|
Collaborators and Investigators
Sponsor
Investigators
- Frederic Viret, MD, Institut Paoli-Calmettes
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- CDR0000416120
- FRE-FNCLCC-GERICO-02/0301
- EU-20500
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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