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

NCT00026338 | Completed Phase 3 DMC FDA Drug

• 4 other identifiers: PA3CAN-NCIC-PA3OSI-CAN-NCIC-PA3CDR0000069020
• Study Type: interventional
• Target: 569
• Locations: 19 countries
• Sites: 173

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.

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 years

Secondary Outcomes (6)

• Progression free survival

  3 years

• Quality of Life

  3 years

• Response rates

  3 years

• Toxicity

  3 years

• EGFR levels

  3 years

Study Arms (2)

OSI-774 plus Gemcitabine

ACTIVE COMPARATOR

Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride

Placebo plus gemcitabine

ACTIVE COMPARATOR

Drug: gemcitabine hydrochloride

Interventions

erlotinib hydrochloride DRUG

150 mg po daily

OSI-774 plus Gemcitabine

gemcitabine hydrochloride DRUG

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)

OSI-774 plus Gemcitabine; Placebo plus gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (173)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72764, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Sutter Health West Cancer Research Group

Greenbrae, California, 94904, United States

Location

Loma Linda University Cancer Institute

Loma Linda, California, 92354, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Kenmar Research Institute

Los Angeles, California, 90057, United States

Location

Century City Hospital

Los Angeles, California, 90067, United States

Location

David Geffen School of Medicine

Los Angeles, California, 90095-7059, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Davis, Posteraro, & Wasser, MDs, LLP

Manchester, Connecticut, 06040, United States

Location

New Britain General Hospital

New Britain, Connecticut, 06050-2000, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Hematology Oncology, P.C.

Stamford, Connecticut, 06902, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471-5563, United States

Location

Oncology & Hematology Associates of West Broward

Tamarac, Florida, 33321, United States

Location

Moffitt Clinic at Tampa General Hospital

Tampa, Florida, 33612-9497, United States

Location

Central Georgia Hematology Oncology, P.C.

Macon, Georgia, 31201, United States

Location

Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Northwest Medical Specialists, P.C.

Arlington Heights, Illinois, 60004, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Midwest Cancer Research Group, Inc.

Skokie, Illinois, 60076, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Medical Consultants

Muncie, Indiana, 47304, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7353, United States

Location

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Norton Healthcare Pavilion

Louisville, Kentucky, 40202, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112-2699, United States

Location

Annapolis Medical Specialists

Annapolis, Maryland, 21401, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Tuft-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135-2997, United States

Location

Berkshire Physicians and Surgeons, P.C.

Pittsfield, Massachusetts, 01201, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Midwest Oncology Consortium

Kansas City, Missouri, 64111, United States

Location

New Hampshire Oncology-Hematology PA

Hooksett, New Hampshire, 03106, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Hematology-Oncology Associates

Mount Holly, New Jersey, 08060, United States

Location

Cooper Cancer Institute

Voorhees Township, New Jersey, 08043, United States

Location

Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Arena Oncology Associates

Great Neck, New York, 11021, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Beth Israel Medical Center

New York, New York, 10019, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

University Hospital - Stony Brook

Stony Brook, New York, 11794-8174, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Mid Dakota Clinic, P.C.

Bismarck, North Dakota, 58502-5538, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Earle A. Chiles Research Institute at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Hematology-Oncology Association of NE Pennsylvania

Dunmore, Pennsylvania, 18512, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Charleston Hematology-Oncology, P.A.

Charleston, South Carolina, 29403, United States

Location

Sarah Cannon-Minnie Pearl Cancer Center

Nashville, Tennessee, 37203, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Texas Cancer Care

Fort Worth, Texas, 76104, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Tyler Hematology Oncology, P.A.

Tyler, Texas, 75701, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Hematology & Oncology Associates of Virginia

Mechanicsville, Virginia, 23116, United States

Location

Western Washington Oncology

Olympia, Washington, 98502, United States

Location

Southwest Washington Medical Center

Vancouver, Washington, 98664, United States

Location

Oncology of Wisconsin

Glendale, Wisconsin, 53212, United States

Location

Hospital Britanico

Buenos Aires, 1280, Argentina

Location

Instituto de Oncologia Angel H. Roffo

Buenos Aires, 1417, Argentina

Location

Instituto Alexander Fleming

Buenos Aires, 1426, Argentina

Location

Hospital Churruca

Buenos Aires, 1437, Argentina

Location

Hospital Italiano

Buenos Aires, CP1181ACH, Argentina

Location

Hospital Interzonal De Augudos Euita

Lanús, 1824, Argentina

Location

Confidence Medical Center

San Isidro, 1642, Argentina

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Newcastle Mater Misericordiae Hospital

Newcastle, New South Wales, NSW 2310, Australia

Location

Institute of Oncology

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Ashford Cancer Centre

Ashford, South Australia, 5035, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Austin and Repatriation Medical Centre

Heidelberg, Victoria, 3084, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Peter MacCallum Cancer Institute

Melbourne, 8006, Australia

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Nucleo de Oncologia da Bahia

Bahia, 40170-070, Brazil

Location

Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre

Porto Alegre, 91330-490, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, 05651-901, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Royal Victoria Hospital, Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Peterborough Oncology Clinic

Peterborough, Ontario, K9H 7B6, Canada

Location

Algoma District Medical Group

Sault Ste. Marie, Ontario, P6B 1Y5, Canada

Location

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, L2R 5K3, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Ontario Cancer Institute

Toronto, Ontario, M4X 1K9, Canada

Location

Toronto General Hospital

Toronto, Ontario, M4X 1K9, Canada

Location

Saint Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

L'Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Clinica Las Condes

Santiago, Chile

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

Virchow Klinikum Humboldt Universitaet Berlin

Berlin, D-13353, Germany

Location

Universitaetsklinik und Strahlenklinik - Essen

Essen, D-45122, Germany

Location

Stadtische Kliniken Frankfurt-Hochst

Frankfurt, DOH-65929, Germany

Location

Tumor Biology Center at the Albert - Ludwigs University

Freiburg im Breisgau, D-79106, Germany

Location

Martin Luther Universitaet

Halle, DOH-06112, Germany

Location

Medizinische Universitaetsklinik und Poliklinik

Heidelberg, D-69115, Germany

Location

Universitatsklinik, Saarland

Homburg/Saar, D-66421, Germany

Location

University Wurzburg

Würzburg, D-97070, Germany

Location

University Hospital of Heraklion

Iraklion (Heraklion), Crete, 71110, Greece

Location

Theagenio Medical Institute

Thessaloniki, 540 07, Greece

Location

Hippokration Hospital

Thessaloniki, 54642, Greece

Location

Prince of Wales Hospital

Shatin, New Territories, NT, Hong Kong

Location

Haemek Medical Center

Afula, 18101, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100, Israel

Location

Rabin Medical Center - Golda-Hasharon Campus

Petah Tikva, 49372, Israel

Location

Kaplan Hospital

Rehovot, 76100, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Policlinico - Cattedra di Ematologia

Palermo, 90100, Italy

Location

Instituto Nac de Cancerologia

Tlalpan, Mexico City, 22, Mexico

Location

Centro Estatal de Cancerologia

Dviango, 34000, Mexico

Location

Auckland Hospital

Auckland, 1, New Zealand

Location

Christchurch Hospital

Christchurch, 1, New Zealand

Location

Great Poland Cancer Center

Poznan, 61 866, Poland

Location

Dolnoslaskie Centrum Oncology

Wroclaw, 53-413, Poland

Location

Institute of Oncology - Bucarest

Bucharest, RO 72435, Romania

Location

Institutul Oncologic-Universitatea de Medicina

Cluj-Napoca, 3400, Romania

Location

St. Spiridon University Hospital

Lasi, 6600, Romania

Location

Clinical County Hospital of Sibiu

Sibiu, 2400, Romania

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 168609, Singapore

Location

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

Queen Elizabeth Hospital

Birmingham, England, B18 7QH, United Kingdom

Location

North Middlesex Hospital

Edmonton, London, England, NI8 1QX, United Kingdom

Location

St. Luke's Cancer Center

Guildford, England, GU2 5XX, United Kingdom

Location

Princess Royal Hospital

Hull, England, HU8 9HE, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Guy's and St. Thomas' Hospitals NHS Trust

London, England, SE1 9RT, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Northern Centre for Cancer Treatment

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Belfast City Hospital Trust

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 17452677 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Malcolm J. Moore, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: October 29, 2001
• Primary Completion: September 17, 2004
• Study Completion: February 10, 2009
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (74); CA (28); CL (1); DE (8); AU (11); BR (3); ME (2); IT (1); SG (3); GR (3); IL (7); NZ (2); GB (13); HK (1); AR (7); CN (2); PL (2); RO (4)