NCT00026338

Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 569 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	150 mg po daily
DRUG	gemcitabine hydrochloride	1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)

Timeline

• Start date: 2001-10-29
• Primary completion: 2004-09-17
• Completion: 2009-02-10
• First posted: 2003-01-27
• Last updated: 2020-04-02

Locations

173 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Germany, Greece, Hong Kong, Israel, Italy, Mexico, New Zealand, Poland, Romania, Singapore, United Kingdom

Regulatory

• FDA-regulated drug study