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Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

NCT00609622 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2012-10-11

Study results available
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Summary

This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

sunitinib

Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).

DRUG

mFOLFOX6

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

DRUG

bevacizumab

Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.

DRUG

mFOLFOX6

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Denmark
  • Germany
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00609622 on ClinicalTrials.gov