This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
Given once daily
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer
Time frame: 2 years
to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774
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