Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Colorectal Neoplasms

Treatments: Drug: sunitinib + FOLFOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT00599924

A6181048

Details and patient eligibility

About

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.

Full description

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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Single arm

Experimental group

Description:

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

Treatment:

Drug: sunitinib + FOLFOX

Drug: sunitinib + FOLFOX

Drug: sunitinib + FOLFOX

Drug: sunitinib + FOLFOX

Drug: sunitinib + FOLFOX

Drug: sunitinib + FOLFOX

Drug: sunitinib + FOLFOX