NCT00215982

Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer

A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	Capecitabine 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.
DRUG	Oxaliplatin	Oxaliplatin 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.
DRUG	Irinotecan	Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-09-22
• Last updated: 2013-11-25

Locations

2 sites across 2 countries: United States, Puerto Rico