Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
Colorectal Neoplasms, Neoplasms
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring advanced solid tumors,, colorectal cancer,, sunitinib (SUTENT),, FOLFOX
Eligibility Criteria
Inclusion Criteria:
- Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria:
- Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens
- Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
- For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Experimental
Single arm
SU011248 [sunitinib] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle. 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion