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
Recruitment status was Active, not recruiting
Sponsor:
UNICANCER
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
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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 |
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 | |
| 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Oxaliplatin Capecitabine Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013