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Sponsored by: |
Odense University Hospital |
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Information provided by: | Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT00212615 |
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes). Bloodsamples will be collected and frozen and later examined for potential predictive factors
Condition | Intervention | Phase |
---|---|---|
C04.588.274.476.411.307 |
Drug: Oxaliplatin (Eloxatin) Drug: Capecitabine (Xeloda) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study |
Official Title: | XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-Line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study |
Estimated Enrollment: | 116 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | October 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Oncology, Herning Hospital | |
Herning, Denmark, 7400 | |
Department of Oncology, Naestved Hospital | |
Naestved, Denmark, 4700 | |
Department of Oncology, Herlev University Hospital | |
Herlev, Denmark, 2730 | |
Department of Oncology, Hilleroed Hospital | |
Hilleroed, Denmark, 3400 | |
Department of Oncology, Roskilde Hospital | |
Roskilde, Denmark, 4000 | |
Department of Oncology, Esbjerg Hospital | |
Esbjerg, Denmark, 6700 | |
Sweden | |
Department of Oncology, Uppsala University Hospital | |
Uppsala, Sweden, 751 85 | |
Department of Oncology, Radiumhemmet | |
Stockholm, Sweden, 100 26 |
Principal Investigator: | Per Pfeiffer, MD | Department of Oncology, Odense University Hospital |
Study ID Numbers: | XELOX III, KFE 03.17 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00212615 History of Changes |
Health Authority: | Denmark: Central Scientific Ethical Committee |
Colorectal neoplasm Capecitabine (Xeloda) Oxaliplatin (Eloxatin) Advanced disease |
Metastatic disease First-line treatment Phase II study |
Antimetabolites Capecitabine Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Immunosuppressive Agents |
Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Immunosuppressive Agents |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |