Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

Summary

The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

Conditions

• Metastatic Colorectal Cancer

Interventions

DRUG

5 fluorouracil

400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days

DRUG

irinotecan

180mg/m2 iv day 1 every 14 days

DRUG

levo- leucovorin

200mg/m2 iv; day 1 every 14 days

DRUG

sunitinib

37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period

DRUG

5 fluorouracil

400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days

DRUG

irinotecan

180mg/m2 iv day 1 every 14 days

DRUG

levo- leucovorin

200mg/m2 iv; day 1 every 14 days

DRUG

placebo

37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2010-03-31

Completion

2010-03-31

Countries

• Argentina
• Australia
• Austria
• Belgium
• Bosnia and Herzegovina
• Brazil
• Bulgaria
• Canada
• Chile
• Colombia
• Cyprus
• Czechia
• Germany
• Hong Kong
• Hungary
• India
• Ireland
• Mexico
• Norway
• Poland
• Portugal
• Romania
• Russia
• Serbia
• Singapore
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand
• Ukraine
• United Kingdom

Study Locations