Pancreatic Cancer Clinical Trial
Official title:
A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Biological therapies such as erlotinib use different ways to
stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and
biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more
effective with or without erlotinib in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and
without erlotinib in treating patients who have unresectable locally advanced or metastatic
pancreatic cancer.
OBJECTIVES:
- Compare the overall survival rate in patients with unresectable locally advanced or
metastatic pancreatic cancer treated with gemcitabine with or without erlotinib.
- Compare the progression-free survival rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the response rate and response duration in patients treated with these regimens.
- Compare the nature, severity, and frequency of toxic effects of these regimens in these
patients.
- Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis
with outcome and response in patients treated with these regimens.
- Determine the pharmacokinetics of erlotinib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center, extent of disease (locally advanced vs
metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two
treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and
43 of course 1 only, which lasts 8 weeks, and on days 1, 8, and 15 of all subsequent
courses, which last 4 weeks each. Patients also receive 1 of 2 doses of oral erlotinib
once daily.
- Arm II: Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once
daily.
Treatment continues in both arms in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent
courses, at 4 weeks after study, and then every 12 weeks until disease progression.
Patients are followed at 4 weeks and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this
study within 11 months.
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