AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pancreatic Neoplasms

Treatments: Drug: AG-013736; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219557

2005-000053-30 (EudraCT Number)

A4061016

Details and patient eligibility

About

This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
• no prior therapy for metastatic disease

Exclusion criteria

• patients with locally advanced disease who are candidates for radiation therapy.
• uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Gemcitabine

Active Comparator group

Treatment:

Drug: Gemcitabine

Drug: Gemcitabine

Axitinib [AG-013736] plus gemcitabine

Experimental group

Treatment:

Drug: Gemcitabine

Drug: AG-013736

Drug: Gemcitabine