Advanced Unresectable Pancreatic Cancer Clinical Trial
Official title:
"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.
| Status | Terminated |
| Enrollment | 360 |
| Est. completion date | August 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas. 2. Adequate hematological parameters: Hemoglobin >/= 9.5 g/dL [SI units, 5.9 mmol/L] WBC >/= 3000/mm3 [SI units, >/= 3 x 109/L] Platelets >/= 100,000/mm3 [SI units, >/= 100 x 109/L] 3. Adequate baseline liver function: Total Bilirubin < 3x ULN and Without liver metastases: AST (SGOT) </= 2.5 x ULN ALT (SGPT) </= 2.5 x ULN With liver metastases: AST (SGOT) </= 5 x ULN ALT (SGPT) </= 5 x ULN 4. Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L]. 5. Performance status ECOG 0-1. 6. Male or female 18 - 75 years inclusive. 7. Minimum life expectancy of 3 months. 8. Written informed consent. Exclusion Criteria: 1. Treatment with chemotherapy for pancreatic cancer. 2. Treatment with other investigational drugs within the last 4 weeks prior to inclusion 3. Immune-suppressive therapy <4 weeks prior to inclusion 4. Chronic corticosteroid use except for asthma inhalers / topical use 5. Radiotherapy within 8 weeks of randomisation. 6. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix. 7. Known diagnosis of HIV (AIDS), Hepatitis B, C. 8. Known history of or co-existing autoimmune disease. 9. Known CNS metastases. 10. Clinically significant serious disease or organ system disease not currently controlled on present therapy. 11. Pregnancy or lactation. 12. Women of childbearing potential not using reliable and adequate contraceptive methods* 13. Known sensitivity to any components of vaccine, gemcitabine or GM-CSF. 14. Unable for any other reason to comply with the protocol (treatment or assessments). - Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Wesley Research Institute Limited | Auchenflower Qld | |
| Australia | Flinders Medical Centre, Medical Oncology - Clinical Trials | Bedford Park | South Australia |
| Australia | Box Hill Hospital, ECRU Oncology | Box Hill | Victoria |
| Australia | The Townsville Hospital, Townsville Cancer Centre | Douglas | Queensland |
| Australia | Fremantle Hospital, Haemtology Department | Fremantle | Western Australia |
| Australia | Royal Hobart Hospital, Centre for Clinical Research | Hobart | Tasmania |
| Australia | St George Hospital, Department of Medical Oncology | Kogarah | New South Wales |
| Australia | The Alfred Hospital, Medical Oncology Unit | Melbourne | Victoria |
| 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 | Westmead Hospital, Dept. of Medical Oncology and Palliative Care | Westmead | New South Wales |
| Australia | Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital | Woodville South | South Australia |
| Belgium | Erasms University Hospital | Brussels | |
| Belgium | Hospital De Jolimont | Bruxelles | |
| Belgium | Ghent University Hospital, Digestive Oncology | Ghent | |
| Denmark | Oncology Department, Århus Hospital | Århus | |
| Denmark | Oncology Department, Herlev Hospital | Herlev | |
| Denmark | Odense Universitetshospital, Onkologisk afd. R | Odense | |
| France | 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 | |
| Ireland | 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 | |
| Italy | 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 | |
| Netherlands | VU University Medical Center | Amsterdam | |
| Norway | 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 | |
| Poland | 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 | |
| Spain | 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 | Clínica Puerta de Hierro, Departamento de Oncología | Madrid | |
| Spain | Fundaci?n Hospital de Alcorc?n, Unidad de Oncología | Madrid | |
| Spain | H. Monteprincipe | Madrid | |
| Spain | Hospital Universitario Gregorio Marañón, Departamento de Oncología | Madrid | |
| Spain | Hospital Universitario La Paz, Departamento 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 | |
| Sweden | 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 | Department of Oncology, Karolinska Universitetssjukhuset | Stockholm | |
| Sweden | Karolinska Institute / Hospital Solna, Department of Oncology | Stockholm | |
| United States | Southwest Regional Cancer Center | Austin | Texas |
| United States | Billings Clinic | Billings | Montana |
| United States | The Center for Hematology-Oncology | Boca Raton | Florida |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Carolinas Hematology Oncology Associates | Charlotte | North Carolina |
| United States | Hematology Oncology Specialists, Covington | Covington | Louisiana |
| 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 | Genesis Cancer Center | Hot Springs | Arkansas |
| United States | Oncology Consultants, PA | Houston | Texas |
| United States | Scripps Clinic Torrey Pines | La Jolla | California |
| United States | University of South Alabama Mitchell Cancer Institute | Mobile | Alabama |
| United States | Oncology Hematology Associates of Central Illinois, PC | Peoria | Illinois |
| United States | Berskhire Hematology Oncology PC | Pittsfield | Massachusetts |
| United States | Portneuf Cancer Center | Pocatello | Idaho |
| United States | Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California |
| United States | Tampa General Hospital Usf Digestive Disorders Centre | Tampa | Florida |
| United States | Toledo Community Hospital Oncology Program | Toledo | Ohio |
| United States | Palm Beach Cancer Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pharmexa A/S | CIRION Central Laboratory, Dorevitch, ICON Clinical Research, INC Research, ORION Clinical Services |
United States, Australia, Belgium, Denmark, France, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival time | 12 month | Yes | |
| Secondary | Progression Free Survival | Time of progression | Yes |