Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Study ID
- NCT00215982
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- capecitabine — DRUGCapecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2. Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle.
- Oxaliplatin — DRUGOxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days.
- Irinotecan — DRUGIrinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.
Study Details
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.
Key Dates
- Start date
- Dec 31, 2004
- Status verified
- Sep 2010
- Primary completion
- Jul 31, 2007
- Completion
- Jul 31, 2007
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Combination TherapyCapecitabine in Combination with Irinotecan and Oxaliplatin
Primary Outcome Measure
response rate [ Time Frame: average of 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | - |
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