NCT00125021

Tarceva and Capecitabine for Pancreatic Cancer

A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.

Detailed description

Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.

Conditions

• Pancreatic Cancer
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Capecitabine	Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
DRUG	OSI-774	Given once daily

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-06-01
• Completion: 2008-09-01
• First posted: 2005-07-29
• Last updated: 2009-11-02

Locations

3 sites across 1 country: United States