Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

Completed · Phase 1

Conditions studied: Colorectal Neoplasms, Neoplasms

In brief

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.

Key facts

Study ID

NCT00599924

Run by

Pfizer

People needed

53

Starts

2005-09-01

Expected to finish

2008-11-01

Last updated by the study team

2015-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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