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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Drug: sunitinib; Drug: mFOLFOX6; Drug: bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00609622

A6181104

Details and patient eligibility

About

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.

Full description

The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease
• Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
• Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion criteria

• Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer
• Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease
• History of cardiac disease
• Brain mets

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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191 participants in 2 patient groups

A

Experimental group

Description:

Treatment arm A - sunitinib plus mFOLFOX6

Treatment:

Drug: mFOLFOX6

Drug: mFOLFOX6

Drug: sunitinib

B

Active Comparator group

Description:

Treatment arm B - bevacizumab plus mFOLFOX6

Treatment:

Drug: mFOLFOX6

Drug: bevacizumab

Drug: mFOLFOX6