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Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

Pfizer logo

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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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