A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall survival
3 years
No
Malcolm J. Moore, MD
Study Chair
Princess Margaret Hospital, Canada
Canada: Health Canada
PA3
NCT00026338
August 2001
February 2009
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Sarah Cannon-Minnie Pearl Cancer Center | Nashville, Tennessee 37203 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Beth Israel Medical Center | New York, New York 10003 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
St. Barnabas Medical Center | Livingston, New Jersey 07039 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Lucille Parker Markey Cancer Center, University of Kentucky | Lexington, Kentucky 40536-0093 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Staten Island University Hospital | Staten Island, New York 10305 |
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
Mountain States Tumor Institute | Boise, Idaho 83712 |
Tuft-New England Medical Center | Boston, Massachusetts 02111 |
Cooper Cancer Institute | Camden, New Jersey 08103 |
Southwest Regional Cancer Center | Austin, Texas 78705 |
Sutter Health West Cancer Research Group | Greenbrae, California 94904 |
New Britain General Hospital | New Britain, Connecticut 06050 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
Arlington Cancer Center | Arlington, Texas 76012 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Ocala Oncology Center | Ocala, Florida 34474 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northwest Medical Specialists, P.C. | Arlington Heights, Illinois 60004 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
Midwest Cancer Research Group, Inc. | Skokie, Illinois 60077 |
Carle Cancer Center | Urbana, Illinois 61801 |
Mid Dakota Clinic, P.C. | Bismarck, North Dakota 58501 |
Tulane Cancer Center | New Orleans, Louisiana 70112 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
Arena Oncology Associates | Great Neck, New York 11021 |
Midwest Oncology Consortium | Kansas City, Missouri 64111 |
St. Elizabeth's Medical Center | Boston, Massachusetts 02135-2997 |
Norton Healthcare Pavilion | Louisville, Kentucky 40202 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Loma Linda University Cancer Institute | Loma Linda, California 92354 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Hematology Oncology, P.C. | Stamford, Connecticut 06902 |
Berkshire Physicians and Surgeons, P.C. | Pittsfield, Massachusetts 01201 |
University Hospital - Stony Brook | Stony Brook, New York 11794-8174 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
Texas Cancer Care | Fort Worth, Texas 76104 |
Hematology & Oncology Associates of Virginia | Richmond, Virginia 23226 |
Charleston Hematology-Oncology, P.A. | Charleston, South Carolina 29403 |
Central Georgia Hematology Oncology, P.C. | Macon, Georgia 31201 |
Oncology & Hematology Associates of West Broward | Tamarac, Florida 33321 |
Kenmar Research Institute | Los Angeles, California 90057 |
Southwest Washington Medical Center | Vancouver, Washington 98664 |
David Geffen School of Medicine | Los Angeles, California 90095-7059 |
Century City Hospital | Los Angeles, California 90067 |
Davis, Posteraro, & Wasser, MDs, LLP | Manchester, Connecticut 06040 |
Moffitt Clinic at Tampa General Hospital | Tampa, Florida 33612-9497 |
Medical Consultants | Muncie, Indiana 47304 |
Metairie, Louisiana 70006 | |
Annapolis Medical Specialists | Annapolis, Maryland 21401 |
New Hampshire Oncology-Hematology PA | Hooksett, New Hampshire 03106 |
Hematology-Oncology Associates | Mount Holly, New Jersey 08060 |
Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Hematology-Oncology Association of NE Pennsylvania | Dunmore, Pennsylvania 18512 |
Tyler Hematology Oncology, P.A. | Tyler, Texas 75701 |
Western Washington Oncology | Olympia, Washington 98502 |
Oncology of Wisconsin | Glendale, Wisconsin 53212 |