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
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.
Interventional
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
1 year
Yes
Andrew X. Zhu, MD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
05-439
NCT00361244
July 2006
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |