Conditions: Colorectal Neoplasms Neoplasms
Keywords: advanced solid tumors, colorectal cancer, sunitinib (SUTENT), FOLFOX
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 53
Healthy volunteers: no

Brief summary:
This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX \[Leucovorin + Fluorouracil (5-FU) + Oxaliplatin\]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.

Detailed description:
Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.

Arms:
arm 1: 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

Interventions: intervention 1: sunitinib + FOLFOX intervention 2: sunitinib + FOLFOX intervention 3: sunitinib + FOLFOX intervention 4: sunitinib + FOLFOX intervention 5: sunitinib + FOLFOX intervention 6: sunitinib + FOLFOX intervention 7: sunitinib + FOLFOX
Intervention descriptions: intervention 1: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 2: 50 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 3: 50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2) intervention 4: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2) intervention 5: 50 mg sunitinib + modified FOLFOX6 (Schedule 4/2) intervention 6: 37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing) intervention 7: 25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

Protocol document: