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SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer

Colorectal Carcinoma Clinical Trial

Official title:
A Phase I/II Study of SU011248 (Sutent) in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Patients With Stage IV Colorectal Cancer

Clinical Trial Summary

The purpose of this study is to determine the safety of SU011248 and the highest dose of this drug that can be given safely in combination with the chemotherapy drugs irinotecan and cetuximab. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further. Other studies have demonstrated the possibility that SU011248 may enhance the anti-tumor activity of other chemotherapy drugs such as irinotecan and cetuximab.

Clinical Trial Description

- Participants will be given a supply of SU011248 capsules to take at home in the morning for two weeks. After taking the capsules for two weeks, there will be a one-week rest period.

- Irinotecan will be administered on days 1 and 8 of every 21-day cycle as an intravenous infusion over 90 minutes. Cetuximab will be administered intravenously on days 1, 8 and 15 of every 21-day cycle. The first treatment of cetuximab is a larger dose. Beginning with the second treatment, the participant will receive a smaller dose of cetuximab.

- Blood work will be repeated at every clinic visit on days 1 and 8. During cycle 1, blood will also be drawn on day 15.

- Tumor assessments will be repeated after 6 weeks, 12 weeks, and every 9 weeks thereafter, and will be assessed by both a CT scan of the abdomen, pelvis, and a chest x-ray. MUGA scans will be repeated every 4 cycles (12 weeks).

- Participants may continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00361244
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date July 2006
Completion date August 2010
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