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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104689 |
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 |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | July 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of colorectal adenocarcinoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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 |
Investigator: | Frederic Viret, MD | Institut Paoli-Calmettes |
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 |
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
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 |
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 |