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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026338 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer |
| Study Start Date: | August 2001 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
No post-surgical malabsorption characterized by:
Ophthalmic:
No significant ophthalmologic abnormalities, including the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Highlands Oncology Group | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| Century City Hospital | |
| Los Angeles, California, United States, 90067 | |
| David Geffen School of Medicine | |
| Los Angeles, California, United States, 90095-7059 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Loma Linda University Cancer Institute | |
| Loma Linda, California, United States, 92354 | |
| Sutter Health West Cancer Research Group | |
| Greenbrae, California, United States, 94904 | |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | |
| San Diego, California, United States, 92120 | |
| United States, Connecticut | |
| Davis, Posteraro, & Wasser, MDs, LLP | |
| Manchester, Connecticut, United States, 06040 | |
| Eastern Connecticut Hematology and Oncology Associates | |
| Norwich, Connecticut, United States, 06360 | |
| Hematology Oncology, P.C. | |
| Stamford, Connecticut, United States, 06902 | |
| New Britain General Hospital | |
| New Britain, Connecticut, United States, 06050-2000 | |
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Moffitt Clinic at Tampa General Hospital | |
| Tampa, Florida, United States, 33612-9497 | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34471-5563 | |
| Oncology & Hematology Associates of West Broward | |
| Tamarac, Florida, United States, 33321 | |
| Oncology-Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| United States, Georgia | |
| Central Georgia Hematology Oncology, P.C. | |
| Macon, Georgia, United States, 31201 | |
| United States, Idaho | |
| Mountain States Tumor Institute | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Midwest Cancer Research Group, Inc. | |
| Skokie, Illinois, United States, 60076 | |
| Northwest Medical Specialists, P.C. | |
| Arlington Heights, Illinois, United States, 60004 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
| Hines, Illinois, United States, 60141 | |
| United States, Indiana | |
| Medical Consultants | |
| Muncie, Indiana, United States, 47304 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| United States, Kentucky | |
| Lucille Parker Markey Cancer Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Norton Healthcare Pavilion | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Metairie, Louisiana, United States, 70006 | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Tulane Cancer Center | |
| New Orleans, Louisiana, United States, 70112-2699 | |
| United States, Maryland | |
| Annapolis Medical Specialists | |
| Annapolis, Maryland, United States, 21401 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| Berkshire Physicians and Surgeons, P.C. | |
| Pittsfield, Massachusetts, United States, 01201 | |
| St. Elizabeth's Medical Center | |
| Boston, Massachusetts, United States, 02135-2997 | |
| Tuft-New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Midwest Oncology Consortium | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New Hampshire | |
| New Hampshire Oncology-Hematology PA | |
| Hooksett, New Hampshire, United States, 03106 | |
| United States, New Jersey | |
| Cooper Cancer Institute | |
| Voorhees, New Jersey, United States, 08043 | |
| Hematology-Oncology Associates | |
| Mount Holly, New Jersey, United States, 08060 | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Arena Oncology Associates | |
| Great Neck, New York, United States, 11021 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10019 | |
| University Hospital - Stony Brook | |
| Stony Brook, New York, United States, 11794-8174 | |
| Interlakes Oncology/Hematology PC | |
| Rochester, New York, United States, 14623 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
| Cancer Center at Glens Falls Hospital | |
| Glens Falls, New York, United States, 12801 | |
| United States, North Carolina | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, North Dakota | |
| Mid Dakota Clinic, P.C. | |
| Bismarck, North Dakota, United States, 58502-5538 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Earle A. Chiles Research Institute at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Hematology-Oncology Association of NE Pennsylvania | |
| Dunmore, Pennsylvania, United States, 18512 | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Charleston Hematology-Oncology, P.A. | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Tennessee | |
| Sarah Cannon-Minnie Pearl Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Arlington Cancer Center | |
| Arlington, Texas, United States, 76012 | |
| Southwest Regional Cancer Center | |
| Austin, Texas, United States, 78705 | |
| Texas Cancer Care | |
| Fort Worth, Texas, United States, 76104 | |
| Tyler Hematology Oncology, P.A. | |
| Tyler, Texas, United States, 75701 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Vermont | |
| Green Mountain Oncology Group | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Hematology & Oncology Associates of Virginia | |
| Mechanicsville, Virginia, United States, 23116 | |
| United States, Washington | |
| Southwest Washington Medical Center | |
| Vancouver, Washington, United States, 98664 | |
| Western Washington Oncology | |
| Olympia, Washington, United States, 98502 | |
| United States, Wisconsin | |
| Oncology of Wisconsin | |
| Glendale, Wisconsin, United States, 53212 | |
| Argentina | |
| Confidence Medical Center | |
| San Isidro, Argentina, 1642 | |
| Hospital Britanico | |
| Buenos Aires, Argentina, 1280 | |
| Hospital Churruca | |
| Buenos Aires, Argentina, 1437 | |
| Hospital Interzonal De Augudos Euita | |
| Lanus, Argentina, 1824 | |
| Hospital Italiano | |
| Buenos Aires, Argentina, CP1181ACH | |
| Instituto Alexander Fleming | |
| Buenos Aires, Argentina, 1426 | |
| Instituto de Oncologia Angel H. Roffo | |
| Buenos Aires, Argentina, 1417 | |
| Australia | |
| Peter MacCallum Cancer Institute | |
| Melbourne, Australia, 8006 | |
| Australia, New South Wales | |
| Concord Repatriation General Hospital | |
| Concord, New South Wales, Australia, 2139 | |
| Institute of Oncology | |
| Randwick, New South Wales, Australia, 2031 | |
| Liverpool Hospital | |
| Liverpool, New South Wales, Australia, 2170 | |
| Newcastle Mater Misericordiae Hospital | |
| Newcastle, New South Wales, Australia, NSW 2310 | |
| Australia, South Australia | |
| Ashford Cancer Centre | |
| Ashford, South Australia, Australia, 5035 | |
| Queen Elizabeth Hospital | |
| Woodville, South Australia, Australia, 5011 | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Austin and Repatriation Medical Centre | |
| Heidelberg, Victoria, Australia, 3084 | |
| Frankston Hospital | |
| Frankston, Victoria, Australia, 3199 | |
| Australia, Western Australia | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Brazil | |
| Hospital Israelita Albert Einstein | |
| Sao Paulo, Brazil, 05651-901 | |
| Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre | |
| Porto Alegre, Brazil, 91330-490 | |
| Nucleo de Oncologia da Bahia | |
| Bahia, Brazil, 40170-070 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| British Columbia Cancer Agency - Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| British Columbia Cancer Agency | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Penticton Regional Hospital | |
| Penticton, British Columbia, Canada, V2A 3G6 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Treatment and Research Foundation | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Science Centre | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| Algoma District Medical Group | |
| Sault Sainte Marie, Ontario, Canada, P6B 1Y5 | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Credit Valley Hospital | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Hotel Dieu Health Sciences Hospital - Niagara | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Ontario Cancer Institute | |
| Toronto, Ontario, Canada, M4X 1K9 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Peterborough Oncology Clinic | |
| Peterborough, Ontario, Canada, K9H 7B6 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M4X 1K9 | |
| Saint Joseph's Health Centre - Toronto | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| Southlake Regional Health Centre | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Toronto East General Hospital | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Royal Victoria Hospital, Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Hopital Du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| L'Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Chile | |
| Clinica Las Condes | |
| Santiago, Chile | |
| China | |
| Pamela Youde Nethersole Eastern Hospital | |
| Hong Kong, China | |
| Queen Mary Hospital | |
| Hong Kong, China | |
| Germany | |
| Martin Luther Universitaet | |
| Halle, Germany, DOH-06112 | |
| Medizinische Universitaetsklinik und Poliklinik | |
| Heidelberg, Germany, D-69115 | |
| Stadtische Kliniken Frankfurt-Hochst | |
| Frankfurt, Germany, DOH-65929 | |
| Tumor Biology Center at the Albert - Ludwigs University | |
| Freiburg, Germany, D-79106 | |
| Universitaetsklinik und Strahlenklinik - Essen | |
| Essen, Germany, D-45122 | |
| Universitatsklinik, Saarland | |
| Homburg/Saar, Germany, D-66421 | |
| University Wurzburg | |
| Wurzburg, Germany, D-97070 | |
| Virchow Klinikum Humboldt Universitaet Berlin | |
| Berlin, Germany, D-13353 | |
| Greece | |
| Hippokration Hospital | |
| Thessaloniki, Greece, 54642 | |
| Theagenio Medical Institute | |
| Thessaloniki, Greece, 540 07 | |
| Greece, Crete | |
| University Hospital of Heraklion | |
| Iraklion (Heraklion), Crete, Greece, 71110 | |
| Hong Kong | |
| Prince of Wales Hospital | |
| Shatin, New Territories, Hong Kong, NT | |
| Israel | |
| Haemek Medical Center | |
| Afula, Israel, 18101 | |
| Kaplan Hospital | |
| Rehovot, Israel, 76100 | |
| Rabin Medical Center - Beilinson Campus | |
| Petah-Tikva, Israel, 49100 | |
| Rabin Medical Center - Golda-Hasharon Campus | |
| Petah-Tikva, Israel, 49372 | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Tel-Aviv Sourasky Medical Center | |
| Tel-Aviv, Israel, 64239 | |
| Italy | |
| Policlinico - Cattedra di Ematologia | |
| Palermo, Italy, 90100 | |
| Mexico | |
| Centro Estatal de Cancerologia | |
| Dviango, Mexico, 34000 | |
| Mexico, Distrito Federal | |
| Instituto Nac de Cancerologia | |
| Tlalpan, Distrito Federal, Mexico, 22 | |
| New Zealand | |
| Auckland Hospital | |
| Auckland, New Zealand, 1 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 1 | |
| Poland | |
| Dolnoslaskie Centrum Oncology | |
| Wroclaw, Poland, 53-413 | |
| Great Poland Cancer Center | |
| Poznan, Poland, 61 866 | |
| Romania | |
| Clinical County Hospital of Sibiu | |
| Sibiu, Romania, 2400 | |
| Institute of Oncology - Bucarest | |
| Bucarest, Romania, RO 72435 | |
| Institutul Oncologic-Universitatea de Medicina | |
| Cluj-Napoca, Romania, 3400 | |
| St. Spiridon University Hospital | |
| Lasi, Romania, 6600 | |
| Singapore | |
| National Cancer Centre - Singapore | |
| Singapore, Singapore, 169610 | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Singapore General Hospital | |
| Singapore, Singapore, 168609 | |
| United Kingdom | |
| Churchill Hospital | |
| Oxford, United Kingdom, OX3 7LJ | |
| United Kingdom, England | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Guy's and St. Thomas' Hospitals NHS Trust | |
| London, England, United Kingdom, SE1 9RT | |
| New Cross Hospital | |
| Wolverhampton, England, United Kingdom, WV10 0QP | |
| North Middlesex Hospital | |
| Edmonton, London, England, United Kingdom, NI8 1QX | |
| Northern Centre for Cancer Treatment | |
| Newcastle upon Tyne, England, United Kingdom, NE4 6BE | |
| Princess Royal Hospital | |
| Hull, England, United Kingdom, HU8 9HE | |
| Queen Elizabeth Hospital | |
| Birmingham, England, United Kingdom, B18 7QH | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| St. Luke's Cancer Center | |
| Guildford, England, United Kingdom, GU2 5XX | |
| United Kingdom, Northern Ireland | |
| Belfast City Hospital Trust | |
| Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
| United Kingdom, Wales | |
| Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
More Information
| Study ID Numbers: | CDR0000069020, CAN-NCIC-PA3, OSI-CAN-NCIC-PA3 |
| Study First Received: | November 9, 2001 |
| Last Updated: | July 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00026338 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Erlotinib Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |