Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin; Sunitinib

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