Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer
NCT ID: NCT00026338
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
569 participants
INTERVENTIONAL
2001-10-29
2009-02-10
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OSI-774 plus Gemcitabine
erlotinib hydrochloride
150 mg po daily
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)
Placebo plus gemcitabine
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)
Interventions
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erlotinib hydrochloride
150 mg po daily
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)
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced or metastatic disease that is considered unresectable
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 2 times upper limit of normal (ULN)
* AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present)
Renal:
* Creatinine less than 1.5 times ULN
Cardiovascular:
* No uncontrolled high blood pressure
* No unstable angina
* No congestive heart failure
* No myocardial infarction within the past year
* No cardiac ventricular arrhythmias requiring medication
Gastrointestinal:
* No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
* No post-surgical malabsorption characterized by:
* Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR
* Requires IV hyperalimentation
* Pancreatic enzyme supplementation allowed provided that the above criteria are not met
Ophthalmic:
* No ocular inflammation or infection unless fully treated prior to study
* No significant ophthalmologic abnormalities, including the following:
* Severe dry eye syndrome
* Sjogren's syndrome
* Keratoconjunctivitis sicca
* Severe exposure keratopathy
* Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No serious active infection
* No other serious underlying medical, psychological, or geographical condition that would preclude study participation
* No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib
* No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent biologic therapy or immunotherapy
Chemotherapy:
* No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer
* No other concurrent cytotoxic chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Chemotherapy
* At least 4 weeks since prior radiotherapy and recovered
* Prior radiotherapy for local disease allowed if evidence of disease progression has occurred
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 2 weeks since prior major surgery
* No concurrent ophthalmic surgery
Other:
* No prior epidermal growth factor receptor inhibitors
* At least 2 weeks since prior investigational drug
* No other concurrent investigational drugs during and for at least 30 days after study
* No other concurrent anti-cancer therapy
18 Years
120 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Malcolm J. Moore, MD
Role: STUDY_CHAIR
Princess Margaret Hospital, Canada
Locations
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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
Davis, Posteraro, & Wasser, MDs, LLP
Manchester, Connecticut, United States
New Britain General Hospital
New Britain, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Hematology Oncology, P.C.
Stamford, Connecticut, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Oncology-Hematology Group of South Florida
Miami, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States
Moffitt Clinic at Tampa General Hospital
Tampa, Florida, United States
Central Georgia Hematology Oncology, P.C.
Macon, Georgia, United States
Mountain States Tumor Institute
Boise, Idaho, 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
Midwest Cancer Research Group, Inc.
Skokie, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Medical Consultants
Muncie, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare Pavilion
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Annapolis Medical Specialists
Annapolis, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 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
Baystate Medical Center
Springfield, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Midwest Oncology Consortium
Kansas City, Missouri, United States
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Hematology-Oncology Associates
Mount Holly, New Jersey, United States
Cooper Cancer Institute
Voorhees Township, New Jersey, 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
University Hospital - Stony Brook
Stony Brook, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States
Hematology-Oncology Association of NE Pennsylvania
Dunmore, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 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
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Tyler Hematology Oncology, P.A.
Tyler, Texas, United States
Green Mountain Oncology Group
Bennington, Vermont, 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 Britanico
Buenos Aires, , Argentina
Instituto de Oncologia Angel H. Roffo
Buenos Aires, , Argentina
Instituto Alexander Fleming
Buenos Aires, , Argentina
Hospital Churruca
Buenos Aires, , Argentina
Hospital Italiano
Buenos Aires, , Argentina
Hospital Interzonal De Augudos Euita
Lanús, , Argentina
Confidence Medical Center
San Isidro, , 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
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Ashford Cancer Centre
Ashford, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Frankston Hospital
Frankston, Victoria, Australia
Austin and Repatriation Medical Centre
Heidelberg, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Peter MacCallum Cancer Institute
Melbourne, , Australia
Institut Jules Bordet
Brussels, , Belgium
Nucleo de Oncologia da Bahia
Bahia, , Brazil
Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
Porto Alegre, , Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
British Columbia Cancer Agency
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, Canada
Algoma District Medical Group
Sault Ste. Marie, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Ontario Cancer Institute
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Clinica Las Condes
Santiago, , Chile
Pamela Youde Nethersole Eastern Hospital
Hong Kong, , China
Queen Mary Hospital
Hong Kong, , China
Virchow Klinikum Humboldt Universitaet Berlin
Berlin, , Germany
Universitaetsklinik und Strahlenklinik - Essen
Essen, , Germany
Stadtische Kliniken Frankfurt-Hochst
Frankfurt, , Germany
Tumor Biology Center at the Albert - Ludwigs University
Freiburg im Breisgau, , Germany
Martin Luther Universitaet
Halle, , Germany
Medizinische Universitaetsklinik und Poliklinik
Heidelberg, , Germany
Universitatsklinik, Saarland
Homburg/Saar, , Germany
University Wurzburg
Würzburg, , Germany
University Hospital of Heraklion
Iraklion (Heraklion), Crete, Greece
Theagenio Medical Institute
Thessaloniki, , Greece
Hippokration Hospital
Thessaloniki, , Greece
Prince of Wales Hospital
Shatin, New Territories, , Hong Kong
Haemek Medical Center
Afula, , Israel
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Rabin Medical Center - Golda-Hasharon Campus
Petah Tikva, , Israel
Kaplan Hospital
Rehovot, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Policlinico - Cattedra di Ematologia
Palermo, , Italy
Instituto Nac de Cancerologia
Tlalpan, Mexico City, Mexico
Centro Estatal de Cancerologia
Dviango, , Mexico
Auckland Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Great Poland Cancer Center
Poznan, , Poland
Dolnoslaskie Centrum Oncology
Wroclaw, , Poland
Institute of Oncology - Bucarest
Bucharest, , Romania
Institutul Oncologic-Universitatea de Medicina
Cluj-Napoca, , Romania
St. Spiridon University Hospital
Lasi, , Romania
Clinical County Hospital of Sibiu
Sibiu, , Romania
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
National Cancer Centre - Singapore
Singapore, , Singapore
Queen Elizabeth Hospital
Birmingham, England, United Kingdom
North Middlesex Hospital
Edmonton, London, England, United Kingdom
St. Luke's Cancer Center
Guildford, England, United Kingdom
Princess Royal Hospital
Hull, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
London, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Northern Centre for Cancer Treatment
Newcastle upon Tyne, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Belfast City Hospital Trust
Belfast, Northern Ireland, United Kingdom
Velindre Hospital
Cardiff, Wales, United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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References
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Dhani NC, Tu D, Parulekar W, et al.: A retrospective analysis of tumor size (TS) as a continuous rather than discrete variable in advanced pancreatic cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-e15565, 2009.
Moore MJ, da Cunha Santos G, Kamel-Reid S, et al.: The relationship of K-ras mutations and EGFR gene copy number to outcome in patients treated with Erlotinib on National Cancer Institute of Canada Clinical Trials Group trial study PA.3. [Abstract] J Clin Oncol 25 (Suppl 18): A-4521, 2007.
Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. doi: 10.1200/JCO.2006.07.9525. Epub 2007 Apr 23.
Moore MJ, Goldstein D, Hamm J, et al.: Erlotinib improves survival when added to gemcitabine in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-77, 2005.
Other Identifiers
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CAN-NCIC-PA3
Identifier Type: OTHER
Identifier Source: secondary_id
OSI-CAN-NCIC-PA3
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000069020
Identifier Type: OTHER
Identifier Source: secondary_id
PA3
Identifier Type: -
Identifier Source: org_study_id
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