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| Sponsor: | OSI Pharmaceuticals |
|---|---|
| Collaborator: |
NCIC Clinical Trials Group |
| Information provided by: | OSI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00040183 |
Purpose
The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Tarceva (erlotinib HCl, OSI-774) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas;cancer which is unresectable, locally advanced or metastatic.
Must have evidence of disease (clinical or radiological). Male or female, 18 years or older. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented.
All toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization.
Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85715 | |
| United States, Arkansas | |
| Highlands Oncology Group | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Metropolitan Hematology/Oncology Medical Group, Inc. | |
| Los Angeles, California, United States, 90057 | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92120 | |
| Loma Linda University Cancer Institute | |
| Loma Linda, California, United States, 92354 | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| United States, Connecticut | |
| DeQuattro Community Cancer Center | |
| Manchester, Connecticut, United States, 06040 | |
| Eastern Connecticut Oncology | |
| Norwich, Connecticut, United States, 06360-2910 | |
| New Britain General Hospital | |
| New Britain, Connecticut, United States, 06050 | |
| Carl and Dorothy Bennett Cancer Center | |
| Stamford, Connecticut, United States, 06902-3628 | |
| United States, Florida | |
| Oncology Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| Florida Cancer Specialists | |
| Ft. Myers, Florida, United States, 34135-4251 | |
| Ocala Oncology | |
| Ocala, Florida, United States, 34474 | |
| United States, Georgia | |
| Atlanta Cancer Center | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Hematology Oncology Associates of Illinois | |
| Skokie, Illinois, United States, 60077 | |
| Onc/Hem Associates of Central Illinois | |
| Peoria, Illinois, United States, 61602 | |
| Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| University of Iowa Hospital & Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Norton Healthcare, Inc. | |
| Louisville, Kentucky, United States, 40202 | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0098 | |
| United States, Louisiana | |
| J Gurtler, Hematology and Oncology | |
| Metairie, Louisiana, United States, 70006 | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| Annapolis Medical Specialists | |
| Annapolis, Maryland, United States, 21401 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01107 | |
| Berkshire Hematology & Oncology, PC | |
| Pittsfield, Massachusetts, United States, 012018298 | |
| St Elizabeth Medical Center | |
| Boston, Massachusetts, United States, 01235 | |
| New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Kansas City Oncology and Hematology Group | |
| 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 | |
| St Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| St Luke's-Roosevelt Hospital | |
| New York, New York, United States, 10019 | |
| Arena Oncology Associates | |
| Great Neck, New York, United States, 11021 | |
| Stony Brook University Hospital | |
| Stony Brook, New York, United States, 11794-8174 | |
| Interlakes Oncology & Hematology, P.C. | |
| Rochester, New York, United States, 14623 | |
| United States, North Carolina | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, North Dakota | |
| Odyssey Research Services | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106-7832 | |
| United States, Oregon | |
| Chiles Research Cancer Center | |
| Portland, Oregon, United States, 97213-2967 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Hematology & Oncolgy Assoc of NE PA | |
| Dunmore, Pennsylvania, United States, 18512 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| United States, South Carolina | |
| Charleston Hematology/Oncology | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Tennessee | |
| Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Arlington Cancer Centre | |
| Arlington, Texas, United States, 76012 | |
| Tyler Hematology Oncology PA | |
| Tyler, Texas, United States, 75701 | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Southwest Regional Cancer Center | |
| Austin, Texas, United States, 78705 | |
| United States, Vermont | |
| Green Mountain Oncology Group | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Hematology & Oncology Associates of Virginia, Ltd. | |
| Richmond, Virginia, United States, 23226 | |
| United States, Washington | |
| Southwest Washington Medical Center | |
| Vancouver, Washington, United States, 98664 | |
| Western Washington Oncology Inc. | |
| Olympia, Washington, United States, 98502 | |
| United States, Wisconsin | |
| Oncology of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Argentina | |
| Hospital Italiano de Buenos Aires | |
| Buenos Aires, Argentina, CP 1181 | |
| Hospital Britanico | |
| Buenos Aires, Argentina, CP 1280 | |
| Instituto Alexander Fleming | |
| Buenos Aires, Argentina, CP 1426 | |
| Hospital Churruca Visca | |
| Buenos Aires, Argentina, CP 1437 | |
| Centro Medico Confidence | |
| Buenos Aires, Argentina, CP 1642 | |
| Instituto Oncologico Angel Roffo | |
| Buenos Aires, Argentina, CP 1417 | |
| Australia, New South Wales | |
| Newcastle Mater Hospital | |
| HRMC Waratah, New South Wales, Australia, 2310 | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Concord Hospital | |
| Concord, New South Wales, Australia, 2139 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| The Queen Elizabeth Hospital | |
| Woodville South, South Australia, Australia, 5011 | |
| Ashford Cancer Centre | |
| Ashford, South Australia, Australia, 5035 | |
| Australia, Victoria | |
| Austin & Repatriation Medical Centre | |
| Heidelberg, Victoria, Australia, 3084 | |
| Frankston Hospital | |
| Frankston, Victoria, Australia, 3199 | |
| Belgium | |
| Institute Jules Bordet | |
| 1000 Brussels, Belgium | |
| Brazil, BA | |
| Nucleo de Oncolgia da Bahia | |
| Salvador, BA, Brazil, 40170-070 | |
| Brazil, Minas Gerais | |
| Hospital Vera Cruz S/A | |
| Barro Preto, Minas Gerais, Brazil, CEP 30190-130 | |
| Brazil, RS | |
| Irmandade Santa Casa de Misericordia de Porto Alegre | |
| Porto Alegre, RS, Brazil, CEP 90020-090 | |
| Brazil, SP | |
| Hospital Israelita Albert Einstein | |
| Sao Paulo, SP, Brazil, 05651-901 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| BC Cancer Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Pentincton Regional Hospital | |
| Pentincton, British Columbia, Canada, V2A 3G6 | |
| Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| BCCA- Vancouver Island Centre | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| BCCA VAncouver Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| CancerCare Manitoba (CCMB) | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, New Brunswick | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Dr. H. Bliss Murphy Cancer Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Hotel Dieu Health Sciences HospitalNiagra | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Group Health Centre | |
| Saulte Ste Marie, Ontario, Canada, P6B 1Y5 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Credit Valley Hospital | |
| Mississauga, Ontario, Canada, L5M 2V8 | |
| Toronto-Sunnybrook Regional Cancer Center | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Toronto East General Hospital | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| St Joseph's Health Centre | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| London Regional Cancer Center | |
| London, Ontario, Canada, N6A 4L6 | |
| Canada, Quebec | |
| Hopital Maisonneuve-Rosemont | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Hopital Laval | |
| Ste Foy, Quebec, Canada, G1V 4G5 | |
| Hopital Du Sacre-Coeur | |
| Montreal, Quebec, Canada, H4J 2C5 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Chile | |
| Clinica Las Condes | |
| Las Condes, Chile | |
| Germany | |
| Tumor Biology Center | |
| Freiburg, Germany, D-79106 | |
| Charite Campus Virchow Klinikum | |
| Berlin, Germany, 13353 | |
| Universitatskliniken des Saarlands Innere Medizin II | |
| Hamburg, Germany, 66421 | |
| Medizinische Poliklinik der Universitaet Wurzburg | |
| Wurzburg, Germany, 97070 | |
| Universitatskliniken des Saarlands | |
| Homburg, Germany, 66421 | |
| Universitatsklinikum Essen | |
| Essen, Germany, 45122 | |
| Innere Medizin Universitatsklinikum Heidelberg | |
| 69115 Heidelberg, Germany | |
| Greece | |
| Anticancer Hospital of Thessaloniki "THEAGENIO" | |
| Thessaloniki, Greece, 546 39 | |
| District General Hospital of Thessaloniki "HIPPOKRATION" | |
| Thessaloniki, Greece, 546 39 | |
| Israel | |
| Kaplan Medical Center | |
| Rehovot, Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Rabin Medical Center (Belinson Campus) | |
| Petach-Tiqva, Israel, 49100 | |
| Sourasky Medical Center (Ichikov) | |
| Tel Aviv, Israel, 64239 | |
| Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica | |
| Palermo, Italy, 90127 | |
| Mexico | |
| Instituto Nacional De Cancerologia | |
| Mexico City, Mexico, 14000 | |
| New Zealand | |
| Auckland Hospital | |
| Auckland, New Zealand, 92019 | |
| Christchurch Hospital Clinical Oncology Hospital | |
| Christchurch, New Zealand | |
| Poland | |
| Dolnoslaskie Centrum Onkologii | |
| Wroclaw, Poland, 53-413 | |
| Great Poland Cancer Centre | |
| Poznan, Poland, 61 866 | |
| Romania | |
| Clinical County Hospital Sibiu | |
| Sibiu, Romania, 2400 | |
| Oncology Institute Ion Chiricuta | |
| Cluj Napoca, Romania, 3400 | |
| St. Spiridon University Hospital | |
| Iasi, Romania, 6600 | |
| Singapore | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Singapore General Hospital | |
| Singapore, Singapore, 169608 | |
| National Cancer Centre | |
| Singapore, Singapore, 169610 | |
| United Kingdom | |
| St. Bartholomews Hospital | |
| London, United Kingdom, EC1A 7BE | |
| The Princess Royal Hospital | |
| Hull, United Kingdom, HU8 9HE | |
| Department of Medical Oncology | |
| Manchester, United Kingdom, M20 4BX | |
| North Middlesex Hospital | |
| London, United Kingdom, N18 1QX | |
| Newcastle General Hospital | |
| Newcastle upon Tyne, United Kingdom, NE4 6BE | |
| United Kingdom, Oxfordshire | |
| ICRF Medical Oncology Unit | |
| Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |
| United Kingdom, Wales | |
| Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| United Kingdom, West Midlands | |
| Deanesly Centre | |
| Wolverhampton, West Midlands, United Kingdom, WV10 0QP | |
| Russell's Hall Hospital Department of Oncology Georgina Unit | |
| Dudley, West Midlands, United Kingdom, DY8 5QX | |
More Information
| Study ID Numbers: | OSI-774-PA3 |
| Study First Received: | June 21, 2002 |
| Last Updated: | January 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00040183 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Tarceva, EGFR, erlotinib, OSI-774 |
|
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 |
