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
- 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
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Andrew X. Zhu, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|