A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
Matthew Kulke, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|