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.
* 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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Given orally in the morning for two weeks followed by a one week rest period (one cycle equals 21 days). Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
Given intravenously on days 1 and 8 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
Given intravenously on days 8 and 15 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
To determine the maximum tolerated dose of SU011248 when given in combination with irinotecan and cetuximab in patients with previously treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma
Time frame: 1 year
To determine the response rate of SU011248 when given in combination with irinotecan and cetuximab in this patient population.
To evaluate the toxicities of this combination of drugs in this patient population
Time frame: 1 year
to assess overall survival, progression-free survival, time to progression and duration of response.
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