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)
Hospital Israelita Albert Einstein
🇧🇷Sao Paulo, Brazil
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Loma Linda University Cancer Institute
🇺🇸Loma Linda, California, United States
Sutter Health West Cancer Research Group
🇺🇸Greenbrae, California, United States
Kenmar Research Institute
🇺🇸Los Angeles, California, United States
Century City Hospital
🇺🇸Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Oncology & Hematology Associates of West Broward
🇺🇸Tamarac, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Central Georgia Hematology Oncology, P.C.
🇺🇸Macon, Georgia, United States
Northwest Medical Specialists, P.C.
🇺🇸Arlington Heights, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Midwest Cancer Research Group, Inc.
🇺🇸Skokie, Illinois, United States
Medical Consultants
🇺🇸Muncie, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Lucille Parker Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Norton Healthcare Pavilion
🇺🇸Louisville, Kentucky, United States
Midwest Oncology Consortium
🇺🇸Kansas City, Missouri, United States
Cancer Center at Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Arena Oncology Associates
🇺🇸Great Neck, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
University Hospital - Stony Brook
🇺🇸Stony Brook, New York, United States
Pennsylvania Oncology Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Hematology-Oncology Association of NE Pennsylvania
🇺🇸Dunmore, Pennsylvania, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Texas Cancer Care
🇺🇸Fort Worth, Texas, United States
Tyler Hematology Oncology, P.A.
🇺🇸Tyler, Texas, United States
Hematology & Oncology Associates of Virginia
🇺🇸Mechanicsville, Virginia, United States
Western Washington Oncology
🇺🇸Olympia, Washington, United States
Southwest Washington Medical Center
🇺🇸Vancouver, Washington, United States
Oncology of Wisconsin
🇺🇸Glendale, Wisconsin, United States
Hospital Italiano
🇦🇷Buenos Aires, Argentina
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
🇦🇺Newcastle, New South Wales, Australia
Institute of Oncology
🇦🇺Randwick, New South Wales, Australia
Peter MacCallum Cancer Institute
🇦🇺Melbourne, Australia
Institut Jules Bordet
🇧🇪Brussels, Belgium
Nucleo de Oncologia da Bahia
🇧🇷Bahia, Brazil
British Columbia Cancer Agency - Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
British Columbia Cancer Agency
🇨🇦Victoria, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Pamela Youde Nethersole Eastern Hospital
🇨🇳Hong Kong, China
Universitaetsklinik und Strahlenklinik - Essen
🇩🇪Essen, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Centro Estatal de Cancerologia
🇲🇽Dviango, Mexico
Institutul Oncologic-Universitatea de Medicina
🇷🇴Cluj-Napoca, Romania
Singapore General Hospital
🇸🇬Singapore, Singapore
North Middlesex Hospital
🇬🇧Edmonton, London, England, United Kingdom
National Cancer Centre - Singapore
🇸🇬Singapore, Singapore
Princess Royal Hospital
🇬🇧Hull, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Davis, Posteraro, & Wasser, MDs, LLP
🇺🇸Manchester, Connecticut, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Tulane Cancer Center
🇺🇸New Orleans, Louisiana, United States
Hematology Oncology, P.C.
🇺🇸Stamford, Connecticut, United States
Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Moffitt Clinic at Tampa General Hospital
🇺🇸Tampa, Florida, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
New Hampshire Oncology-Hematology PA
🇺🇸Hooksett, New Hampshire, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Annapolis Medical Specialists
🇺🇸Annapolis, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Hematology-Oncology Associates
🇺🇸Mount Holly, New Jersey, United States
Tuft-New England Medical Center
🇺🇸Boston, Massachusetts, United States
St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Berkshire Physicians and Surgeons, P.C.
🇺🇸Pittsfield, Massachusetts, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Instituto Alexander Fleming
🇦🇷Buenos Aires, Argentina
Cooper Cancer Institute
🇺🇸Voorhees, New Jersey, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Hospital Churruca
🇦🇷Buenos Aires, Argentina
Charleston Hematology-Oncology, P.A.
🇺🇸Charleston, South Carolina, United States
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
Hospital Britanico
🇦🇷Buenos Aires, Argentina
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Instituto de Oncologia Angel H. Roffo
🇦🇷Buenos Aires, Argentina
Confidence Medical Center
🇦🇷San Isidro, Argentina
Hospital Interzonal De Augudos Euita
🇦🇷Lanus, Argentina
Austin and Repatriation Medical Centre
🇦🇺Heidelberg, Victoria, Australia
Ashford Cancer Centre
🇦🇺Ashford, South Australia, Australia
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Queen Elizabeth Hospital
🇬🇧Birmingham, England, United Kingdom
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
🇧🇷Porto Alegre, Brazil
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Queen Elizabeth II Health Science Centre
🇨🇦Halifax, Nova Scotia, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Peterborough Oncology Clinic
🇨🇦Peterborough, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Algoma District Medical Group
🇨🇦Sault Sainte Marie, Ontario, Canada
Hopital Du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Universitatsklinik, Saarland
🇩🇪Homburg/Saar, Germany
Haemek Medical Center
🇮🇱Afula, Israel
Hotel Dieu Health Sciences Hospital - Niagara
🇨🇦St. Catharines, Ontario, Canada
Virchow Klinikum Humboldt Universitaet Berlin
🇩🇪Berlin, Germany
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Ontario Cancer Institute
🇨🇦Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Medizinische Universitaetsklinik und Poliklinik
🇩🇪Heidelberg, Germany
University Hospital of Heraklion
🇬🇷Iraklion (Heraklion), Crete, Greece
Theagenio Medical Institute
🇬🇷Thessaloniki, Greece
Policlinico - Cattedra di Ematologia
🇮🇹Palermo, Italy
Instituto Nac de Cancerologia
🇲🇽Tlalpan, Distrito Federal, Mexico
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Dolnoslaskie Centrum Oncology
🇵🇱Wroclaw, Poland
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Clinica Las Condes
🇨🇱Santiago, Chile
Stadtische Kliniken Frankfurt-Hochst
🇩🇪Frankfurt, Germany
University Wurzburg
🇩🇪Wurzburg, Germany
Guy's and St. Thomas' Hospitals NHS Trust
🇬🇧London, England, United Kingdom
Tumor Biology Center at the Albert - Ludwigs University
🇩🇪Freiburg, Germany
Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Belfast City Hospital Trust
🇬🇧Belfast, Northern Ireland, United Kingdom
Martin Luther Universitaet
🇩🇪Halle, Germany
Hippokration Hospital
🇬🇷Thessaloniki, Greece
Rabin Medical Center - Golda-Hasharon Campus
🇮🇱Petah-Tikva, Israel
Kaplan Hospital
🇮🇱Rehovot, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Great Poland Cancer Center
🇵🇱Poznan, Poland
St. Spiridon University Hospital
🇷🇴Lasi, Romania
Clinical County Hospital of Sibiu
🇷🇴Sibiu, Romania
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
St. Luke's Cancer Center
🇬🇧Guildford, England, United Kingdom
Auckland Hospital
🇳🇿Auckland, New Zealand
Institute of Oncology - Bucarest
🇷🇴Bucarest, Romania
National University Hospital
🇸🇬Singapore, Singapore
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Oncology-Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Queen Mary Hospital
🇨🇳Hong Kong, China
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Mid Dakota Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Earle A. Chiles Research Institute at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Sarah Cannon-Minnie Pearl Cancer Center
🇺🇸Nashville, Tennessee, United States
Northern Centre for Cancer Treatment
🇬🇧Newcastle upon Tyne, England, United Kingdom
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong