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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: 5 fluorouracil; Drug: irinotecan; Drug: placebo; Drug: levo- leucovorin; Drug: sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457691

A6181122

Details and patient eligibility

About

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.

Full description

On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.

Enrollment: 768 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
• Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
• Adequate organ function defined by blood test.

Exclusion criteria

• History of another primary cancer in the last 3 years.
• Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
• History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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768 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: sunitinib

Drug: 5 fluorouracil

Drug: levo- leucovorin

Drug: levo- leucovorin

Drug: irinotecan

Drug: irinotecan

Drug: 5 fluorouracil

2

Placebo Comparator group

Treatment:

Drug: 5 fluorouracil

Drug: levo- leucovorin

Drug: levo- leucovorin

Drug: irinotecan

Drug: irinotecan

Drug: 5 fluorouracil

Drug: placebo