Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00026338
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 569
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OSI-774 plus Gemcitabine erlotinib hydrochloride - OSI-774 plus Gemcitabine gemcitabine hydrochloride - Placebo plus gemcitabine gemcitabine hydrochloride -
- Primary Outcome Measures
Name Time Method Overall survival 3 years
- Secondary Outcome Measures
Name Time Method Response rates 3 years Complete and partial response only.
Progression free survival 3 years Toxicity 3 years Pharmacokinetics 3 years To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics
Quality of Life 3 years Canada, US and selected countries only
EGFR levels 3 years Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
Trial Locations
- Locations (171)
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Sutter Health West Cancer Research Group
🇺🇸Greenbrae, California, United States
Loma Linda University Cancer Institute
🇺🇸Loma Linda, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Kenmar Research Institute
🇺🇸Los Angeles, California, United States
Century City Hospital
🇺🇸Los Angeles, California, United States
David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Scroll for more (161 remaining)Arizona Clinical Research Center🇺🇸Tucson, Arizona, United States