Spots Global Cancer Trial Database for GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
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Trial Identification
Brief Title: GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
Official Title: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
Study ID: NCT00358566
Conditions
Study Description
Brief Summary: To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.
Detailed Description: The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
Scripps Clinic Torrey Pines, La Jolla, California, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
The Center for Hematology-Oncology, Boca Raton, Florida, United States
Tampa General Hospital Usf Digestive Disorders Centre, Tampa, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Portneuf Cancer Center, Pocatello, Idaho, United States
Oncology Hematology Associates of Central Illinois, PC, Peoria, Illinois, United States
Hematology Oncology Specialists, Covington, Covington, Louisiana, United States
Berskhire Hematology Oncology PC, Pittsfield, Massachusetts, United States
Billings Clinic, Billings, Montana, United States
Carolinas Hematology Oncology Associates, Charlotte, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
Southwest Regional Cancer Center, Austin, Texas, United States
Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas, Dallas, Texas, United States
Mary Crowley Medical Research Center, Worth St., Dallas, Texas, United States
Oncology Consultants, PA, Houston, Texas, United States
St George Hospital, Department of Medical Oncology, Kogarah, New South Wales, Australia
Westmead Hospital, Dept. of Medical Oncology and Palliative Care, Westmead, New South Wales, Australia
The Townsville Hospital, Townsville Cancer Centre, Douglas, Queensland, Australia
Flinders Medical Centre, Medical Oncology - Clinical Trials, Bedford Park, South Australia, Australia
Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital, Woodville South, South Australia, Australia
Royal Hobart Hospital, Centre for Clinical Research, Hobart, Tasmania, Australia
Box Hill Hospital, ECRU Oncology, Box Hill, Victoria, Australia
The Alfred Hospital, Medical Oncology Unit, Melbourne, Victoria, Australia
Fremantle Hospital, Haemtology Department, Fremantle, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Mount Medical Centre, Perth Oncology, Perth, Western Australia, Australia
Royal Perth Hospital, Department of Medical Oncology, Perth, Western Australia, Australia
Wesley Research Institute Limited, Auchenflower Qld, , Australia
Erasms University Hospital, Brussels, , Belgium
Hospital De Jolimont, Bruxelles, , Belgium
Ghent University Hospital, Digestive Oncology, Ghent, , Belgium
Oncology Department, Herlev Hospital, Herlev, , Denmark
Odense Universitetshospital, Onkologisk afd. R, Odense, , Denmark
Oncology Department, Århus Hospital, Århus, , Denmark
Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin, Angers Cedex 01, , France
Oncologie Medicale, Clinic Pasteur, Evreux, , France
Hepatogastroenterology Dpt, University Hospital Center of Grenoble, Grenoble Cedex, , France
Service de Medicine Interne, CHRU de Lille, Lille, , France
Oncologie Midicale CHR Lorient, Lorient, , France
Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale, Moreau, , France
Oncologie Médicale, Centre Cathrine de Siennes, Nantes, , France
Service de Cancerologie, Hospital Europeen Georges Pompidou, Paris, , France
Medical Oncology Dpt, Armoricaine Private Hospital of Radiology, Saint Brieuc, , France
Clinic Saint Vincent, Saint Gregoire, , France
Oncology Trials Unit, Cork University Hospital, Cork, , Ireland
Cancer Clinical Trials Unit, Beaumont Hospital, Dublin, , Ireland
Cancer Research Unit, Mater Misericordlae University Hospital, Dublin, , Ireland
Department of Medical Oncology, Amnch, Dublin, , Ireland
Oncology Research Team, Mater Private University Hospital, Dublin, , Ireland
Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita, Ancona, , Italy
Policlinico Universitario "Mater Domini", Unita Oncologia, Catanzaro, , Italy
Hospital "Careggi", Medical Oncology, Firenze, , Italy
Azienda Ospedaliera, Arcispedale S. Maria Nuova, Reggio Emilia, , Italy
Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma, Verona, , Italy
VU University Medical Center, Amsterdam, , Netherlands
Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology, Bergen, , Norway
Sorlandet Hospital, Senter for Kreftbehandling, Kristiansand, , Norway
Ullevål Universitetssykehus, Gastrokirurgisk afd., Oslo, , Norway
Department of Oncology, University Hospital of Northern-Norway, Tromsoe, , Norway
Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych, Bialystok, , Poland
W.S2.Z, Krolewiecka, Elblag, , Poland
Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii, Krakow, , Poland
Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University, Lodz, , Poland
Zaklad Opieki Zdrowotnej MSWiA, Olsztyn, , Poland
Centrum Onkologii, Wosewodzki Osrodek Onkologii, Opole, , Poland
Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii, Wroclaw, , Poland
Hospital Clinic I Provincial De Barcelona, Barcelona, , Spain
Medical Oncology Department, General Hospital of Baza, Granada, , Spain
Medical Oncology Department, Virgen de Las Nieves Hospital, Granada, , Spain
Hospital Universitario Gregorio Marañón, Departamento de Oncología, Madrid, , Spain
Clínica Puerta de Hierro, Departamento de Oncología, Madrid, , Spain
Hospital Universitario La Paz, Departamento de Oncología, Madrid, , Spain
H. Monteprincipe, Madrid, , Spain
Fundaciόn Hospital de Alcorcόn, Unidad de Oncología, Madrid, , Spain
HRU Carlos Haya, Medical Oncology Unit, Malaga, , Spain
Oncology Department, Clinic Universitary Hospital, Malaga, , Spain
Digestive Unit, Universitary Hospital Virgen de La Macarena, Seville, , Spain
Sahlgrenska Hospital, Head Division for Upper GI Surgery, Goteborg, , Sweden
University Hospital, Department Of surgery and Gasterenterology, Lund, , Sweden
Department of Oncology, Malmö University Hospital, Malmö, , Sweden
Karolinska Institute / Hospital Solna, Department of Oncology, Stockholm, , Sweden
Department of Oncology, Karolinska Universitetssjukhuset, Stockholm, , Sweden
Contact Details
Name: Ask Aabenhus, MSc. (Pharm)
Affiliation: Pharmexa A/S
Role: STUDY_DIRECTOR
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