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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Hoffmann-La Roche |
Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00215982 |
The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
Condition | Intervention | Phase |
Metastatic Colorectal Cancer |
Drug: capecitabine Drug: Oxaliplatin Drug: Irinotecan |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Drug Information available for: | Irinotecan Irinotecan hydrochloride Capecitabine Oxaliplatin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer |
Estimated Enrollment: | 42 |
Study Start Date: | December 2004 |
The primary objective of the study is to determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan. Secondary objectives are to determine the time to tumor progression and the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination. Study schema is as follows. Cycles are 42 days long. Patients will receive Oxaliplatin and Capecitabine on day 1. Capecitabine is an oral pill that will be taken for 14 days. Patients return again on day 21 when they receive Irinotecan and Capecitabine. Capecitabine again is taken for 14 days. CT scans are performed at the end of the 6 week cycle to determine response.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
H. Lee Moffitt Cancer Center & Research Institute | |||||
Tampa, Florida, United States, 33612 |
H. Lee Moffitt Cancer Center and Research Institute |
Hoffmann-La Roche |
Principal Investigator: | Chris Garrett, MD | H. Lee Moffitt Cancer Center and Research Institute |
Moffiitt Cancer Center Clinical Trials website 
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Study ID Numbers: | MCC-13424, USFIRB#101950 |
First Received: | September 19, 2005 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00215982 |
Health Authority: | United States: Food and Drug Administration |
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