Pancreatic Cancer Clinical Trial
Official title:
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
| Verified date | June 2015 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 569 |
| Est. completion date | January 15, 2004 |
| Est. primary completion date | January 15, 2004 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 120 Years |
| Eligibility |
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.' |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Medico Confidence | Buenos Aires | |
| Argentina | Hospital Britanico | Buenos Aires | |
| Argentina | Hospital Churruca Visca | Buenos Aires | |
| Argentina | Hospital Italiano de Buenos Aires | Buenos Aires | |
| Argentina | Instituto Alexander Fleming | Buenos Aires | |
| Argentina | Instituto Oncologico Angel Roffo | Buenos Aires | |
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | Ashford Cancer Centre | Ashford | South Australia |
| Australia | Concord Hospital | Concord | New South Wales |
| Australia | Frankston Hospital | Frankston | Victoria |
| Australia | Austin & Repatriation Medical Centre | Heidelberg | Victoria |
| Australia | Newcastle Mater Hospital | HRMC Waratah | New South Wales |
| Australia | Prince of Wales Hospital | Randwick | New South Wales |
| Australia | The Queen Elizabeth Hospital | Woodville South | South Australia |
| Belgium | Institute Jules Bordet | Brussels | |
| Brazil | Hospital Vera Cruz S/A | Barro Preto | Minas Gerais |
| Brazil | Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS |
| Brazil | Nucleo de Oncolgia da Bahia | Salvador | BA |
| Brazil | Hospital Israelita Albert Einstein | Sao Paulo | SP |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
| Canada | Hamilton Regional Cancer Centre | Hamilton | Ontario |
| Canada | BC Cancer Centre for the Southern Interior | Kelowna | British Columbia |
| Canada | Kingston Regional Cancer Centre | Kingston | Ontario |
| Canada | London Regional Cancer Center | London | Ontario |
| Canada | Credit Valley Hospital | Mississauga | Ontario |
| Canada | Hopital Du Sacre-Coeur | Montreal | Quebec |
| Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
| Canada | Ottawa Regional Cancer Centre | Ottawa | Ontario |
| Canada | Pentincton Regional Hospital | Pentincton | British Columbia |
| Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
| Canada | Saint John Regional Hospital | Saint John | New Brunswick |
| Canada | Group Health Centre | Saulte Ste. Marie | Ontario |
| Canada | Hotel Dieu Health Sciences HospitalNiagra | St. Catharines | Ontario |
| Canada | Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador |
| Canada | Hopital Laval | Ste-Foy | Quebec |
| Canada | Fraser Valley Cancer Centre | Surrey | British Columbia |
| Canada | Princess Margaret Hospital | Toronto | Ontario |
| Canada | St Joseph's Health Centre | Toronto | Ontario |
| Canada | Toronto East General Hospital | Toronto | Ontario |
| Canada | Toronto-Sunnybrook Regional Cancer Center | Toronto | Ontario |
| Canada | BCCA VAncouver Centre | Vancouver | British Columbia |
| Canada | BCCA- Vancouver Island Centre | Victoria | British Columbia |
| Canada | CancerCare Manitoba (CCMB) | Winnipeg | Manitoba |
| Chile | Clinica Las Condes | Las Condes | |
| Germany | Charite Campus Virchow Klinikum | Berlin | |
| Germany | Universitatsklinikum Essen | Essen | |
| Germany | Tumor Biology Center | Freiburg | |
| Germany | Universitatskliniken des Saarlands Innere Medizin II | Hamburg | |
| Germany | Innere MedizinUniversitatsklinikum Heidelberg | Heidelberg | |
| Germany | Universitatskliniken des Saarlands | Homburg | |
| Germany | Medizinische Poliklinik der Universitaet Wurzburg | Wurzburg | |
| Greece | Anticancer Hospital of Thessaloniki "THEAGENIO" | Thessaloniki | |
| Greece | District General Hospital of Thessaloniki "HIPPOKRATION" | Thessaloniki | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Rabin Medical Center (Belinson Campus) | Petach Tiqva | |
| Israel | Kaplan Medical Center | Rehovot | |
| Israel | Sourasky Medical Center (Ichikov) | Tel Aviv | |
| Israel | Chaim Sheba Medical Center | Tel Hashomer | |
| Italy | Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica | Palermo | |
| Mexico | Instituto Nacional De Cancerologia | Mexico City | |
| New Zealand | Auckland Hospital | Auckland | |
| New Zealand | Christchurch HospitalClinical Oncology Hospital | Christchurch | |
| Poland | Great Poland Cancer Centre | Poznan | |
| Poland | Dolnoslaskie Centrum Onkologii | Wroclaw | |
| Romania | Oncology Institute Ion Chiricuta | Cluj-Napoca | |
| Romania | St. Spiridon University Hospital | Iasi | |
| Romania | Clinical County Hospital Sibiu | Sibiu | |
| Singapore | National Cancer Centre | Singapore | |
| Singapore | National University Hospital | Singapore | |
| Singapore | Singapore General Hospital | Singapore | |
| United Kingdom | Velindre Hospital | Cardiff | Wales |
| United Kingdom | Russell's Hall HospitalDepartment of OncologyGeorgina Unit | Dudley | West Midlands |
| United Kingdom | The Princess Royal Hospital | Hull | |
| United Kingdom | North Middlesex Hospital | London | |
| United Kingdom | St. Bartholomews Hospital | London | |
| United Kingdom | Department of Medical Oncology | Manchester | |
| United Kingdom | Newcastle General Hospital | Newcastle-Upon-Tyne | |
| United Kingdom | ICRF Medical Oncology Unit | Oxford | Oxfordshire |
| United Kingdom | Deanesly Centre | Wolverhampton | West Midlands |
| United States | Annapolis Medical Specialists | Annapolis | Maryland |
| United States | Arlington Cancer Centre | Arlington | Texas |
| United States | Atlanta Cancer Center | Atlanta | Georgia |
| United States | Southwest Regional Cancer Center | Austin | Texas |
| United States | Sinai Hospital | Baltimore | Maryland |
| United States | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
| United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
| United States | Green Mountain Oncology Group | Bennington | Vermont |
| United States | Alta Bates Comprehensive Cancer Center | Berkeley | California |
| United States | Odyssey Research Services | Bismarck | North Dakota |
| United States | New England Medical Center | Boston | Massachusetts |
| United States | St Elizabeth Medical Center | Boston | Massachusetts |
| United States | Charleston Hematology/Oncology | Charleston | South Carolina |
| United States | Presbyterian Hospital | Charlotte | North Carolina |
| United States | University Hospitals of Cleveland | Cleveland | Ohio |
| United States | Hematology & Oncolgy Assoc of NE PA | Dunmore | Pennsylvania |
| United States | Florida Cancer Specialists | Fort Myers | Florida |
| United States | Arena Oncology Associates | Great Neck | New York |
| United States | New Hampshire Oncology-Hematology PA | Hooksett | New Hampshire |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | University of Iowa Hospital & Clinics | Iowa City | Iowa |
| United States | Kansas City Oncology and Hematology Group | Kansas City | Missouri |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | St Barnabas Medical Center | Livingston | New Jersey |
| United States | Loma Linda University Cancer Institute | Loma Linda | California |
| United States | Metropolitan Hematology/Oncology Medical Group, Inc. | Los Angeles | California |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | Norton Healthcare, Inc. | Louisville | Kentucky |
| United States | DeQuattro Community Cancer Center | Manchester | Connecticut |
| United States | J Gurtler, Hematology and Oncology | Metairie | Louisiana |
| United States | Oncology Hematology Group of South Florida | Miami | Florida |
| United States | Oncology of Wisconsin | Milwaukee | Wisconsin |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
| United States | New Britain General Hospital | New Britain | Connecticut |
| United States | New York University School of Medicine | New York | New York |
| United States | St Luke's-Roosevelt Hospital | New York | New York |
| United States | Eastern Connecticut Oncology | Norwich | Connecticut |
| United States | Ocala Oncology | Ocala | Florida |
| United States | Western Washington Oncology Inc. | Olympia | Washington |
| United States | Onc/Hem Associates of Central Illinois | Peoria | Illinois |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Pennsylvania Oncology Hematology Associates | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
| United States | Berkshire Hematology & Oncology, PC | Pittsfield | Massachusetts |
| United States | Chiles Research Cancer Center | Portland | Oregon |
| United States | Hematology & Oncology Associates of Virginia, Ltd. | Richmond | Virginia |
| United States | Interlakes Oncology & Hematology, P.C. | Rochester | New York |
| United States | Kaiser Permanente | San Diego | California |
| United States | Hematology Oncology Associates of Illinois | Skokie | Illinois |
| United States | Highlands Oncology Group | Springdale | Arkansas |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | Carl and Dorothy Bennett Cancer Center | Stamford | Connecticut |
| United States | Stony Brook University Hospital | Stony Brook | New York |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Arizona Clinical Research Center | Tucson | Arizona |
| United States | Tyler Hematology Oncology PA | Tyler | Texas |
| United States | Carle Cancer Center | Urbana | Illinois |
| United States | Southwest Washington Medical Center | Vancouver | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| OSI Pharmaceuticals | Canadian Cancer Trials Group |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Germany, Greece, Israel, Italy, Mexico, New Zealand, Poland, Romania, Singapore, United Kingdom,
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. Epub 2007 Apr 23. — View Citation
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