GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
- Conditions
- Advanced Unresectable Pancreatic Cancer
- Interventions
- Biological: GV1001
- Registration Number
- NCT00358566
- Lead Sponsor
- Pharmexa A/S
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 360
-
Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.
-
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]
-
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
-
Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L].
-
Performance status ECOG 0-1.
-
Male or female 18 - 75 years inclusive.
-
Minimum life expectancy of 3 months.
-
Written informed consent.
-
Treatment with chemotherapy for pancreatic cancer.
-
Treatment with other investigational drugs within the last 4 weeks prior to inclusion
-
Immune-suppressive therapy <4 weeks prior to inclusion
-
Chronic corticosteroid use except for asthma inhalers / topical use
-
Radiotherapy within 8 weeks of randomisation.
-
Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.
-
Known diagnosis of HIV (AIDS), Hepatitis B, C.
-
Known history of or co-existing autoimmune disease.
-
Known CNS metastases.
-
Clinically significant serious disease or organ system disease not currently controlled on present therapy.
-
Pregnancy or lactation.
-
Women of childbearing potential not using reliable and adequate contraceptive methods*
-
Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine Gemcitabine (Chemotherapy) Gemcitabine alone treatment. GV1001 GV1001 GV1001 in sequential combination with Gemcitabine
- Primary Outcome Measures
Name Time Method Overall survival time 12 month
- Secondary Outcome Measures
Name Time Method Progression Free Survival Time of progression
Trial Locations
- Locations (86)
The Center for Hematology-Oncology
🇺🇸Boca Raton, Florida, United States
Oncology Consultants, PA
🇺🇸Houston, Texas, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas
🇺🇸Dallas, Texas, United States
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
Fremantle Hospital, Haemtology Department
🇦🇺Fremantle, Western Australia, Australia
Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology
🇳🇴Bergen, Norway
Ullevål Universitetssykehus, Gastrokirurgisk afd.
🇳🇴Oslo, Norway
Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych
🇵🇱Bialystok, Poland
W.S2.Z, Krolewiecka
🇵🇱Elblag, Poland
Centrum Onkologii, Wosewodzki Osrodek Onkologii
🇵🇱Opole, Poland
Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii
🇵🇱Wroclaw, Poland
Cancer Research Unit, Mater Misericordlae University Hospital
🇮🇪Dublin, Ireland
Hematology Oncology Specialists, Covington
🇺🇸Covington, Louisiana, United States
Royal Hobart Hospital, Centre for Clinical Research
🇦🇺Hobart, Tasmania, Australia
Oncology Trials Unit, Cork University Hospital
🇮🇪Cork, Ireland
Oncology Research Team, Mater Private University Hospital
🇮🇪Dublin, Ireland
Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii
🇵🇱Krakow, Poland
Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University
🇵🇱Lodz, Poland
The Alfred Hospital, Medical Oncology Unit
🇦🇺Melbourne, Victoria, Australia
Box Hill Hospital, ECRU Oncology
🇦🇺Box Hill, Victoria, Australia
Cancer Clinical Trials Unit, Beaumont Hospital
🇮🇪Dublin, Ireland
Department of Medical Oncology, Amnch
🇮🇪Dublin, Ireland
VU University Medical Center
🇳🇱Amsterdam, Netherlands
Zaklad Opieki Zdrowotnej MSWiA
🇵🇱Olsztyn, Poland
Hospital De Jolimont
🇧🇪Bruxelles, Belgium
Ghent University Hospital, Digestive Oncology
🇧🇪Ghent, Belgium
Sorlandet Hospital, Senter for Kreftbehandling
🇳🇴Kristiansand, Norway
Oncology Department, Herlev Hospital
🇩🇰Herlev, Denmark
Policlinico Universitario "Mater Domini", Unita Oncologia
🇮🇹Catanzaro, Italy
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Scripps Clinic Torrey Pines
🇺🇸La Jolla, California, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Desert Hematology Oncology Medical Group, Inc.
🇺🇸Rancho Mirage, California, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Portneuf Cancer Center
🇺🇸Pocatello, Idaho, United States
Oncology Hematology Associates of Central Illinois, PC
🇺🇸Peoria, Illinois, United States
Carolinas Hematology Oncology Associates
🇺🇸Charlotte, North Carolina, United States
Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
St George Hospital, Department of Medical Oncology
🇦🇺Kogarah, New South Wales, Australia
The Townsville Hospital, Townsville Cancer Centre
🇦🇺Douglas, Queensland, 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, Australia
Odense Universitetshospital, Onkologisk afd. R
🇩🇰Odense, Denmark
Oncology Department, Århus Hospital
🇩🇰Århus, Denmark
Oncologie Medicale, Clinic Pasteur
🇫🇷Evreux, France
Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita
🇮🇹Ancona, Italy
Clinic Saint Vincent
🇫🇷Saint Gregoire, France
Azienda Ospedaliera, Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
Department of Oncology, University Hospital of Northern-Norway
🇳🇴Tromsoe, Norway
Hospital Clinic I Provincial De Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Gregorio Marañón, Departamento de Oncología
🇪🇸Madrid, Spain
Hospital Universitario La Paz, Departamento de Oncología
🇪🇸Madrid, Spain
Medical Oncology Department, Virgen de Las Nieves Hospital
🇪🇸Granada, Spain
Clínica Puerta de Hierro, Departamento de Oncología
🇪🇸Madrid, Spain
H. Monteprincipe
🇪🇸Madrid, Spain
HRU Carlos Haya, Medical Oncology Unit
🇪🇸Malaga, Spain
Fundaciόn Hospital de Alcorcόn, Unidad de Oncología
🇪🇸Madrid, Spain
Sahlgrenska Hospital, Head Division for Upper GI Surgery
🇸🇪Goteborg, Sweden
Digestive Unit, Universitary Hospital Virgen de La Macarena
🇪🇸Seville, Spain
Tampa General Hospital Usf Digestive Disorders Centre
🇺🇸Tampa, Florida, United States
Berskhire Hematology Oncology PC
🇺🇸Pittsfield, Massachusetts, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Mary Crowley Medical Research Center, Worth St.
🇺🇸Dallas, Texas, United States
Flinders Medical Centre, Medical Oncology - Clinical Trials
🇦🇺Bedford Park, South Australia, Australia
Wesley Research Institute Limited
🇦🇺Auchenflower Qld, Australia
Erasms University Hospital
🇧🇪Brussels, Belgium
Hepatogastroenterology Dpt, University Hospital Center of Grenoble
🇫🇷Grenoble Cedex, France
Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin
🇫🇷Angers Cedex 01, France
Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale
🇫🇷Moreau, France
Oncologie Médicale, Centre Cathrine de Siennes
🇫🇷Nantes, France
Oncologie Midicale CHR Lorient
🇫🇷Lorient, France
Service de Medicine Interne, CHRU de Lille
🇫🇷Lille, France
Service de Cancerologie, Hospital Europeen Georges Pompidou
🇫🇷Paris, France
Medical Oncology Dpt, Armoricaine Private Hospital of Radiology
🇫🇷Saint Brieuc, France
Hospital "Careggi", Medical Oncology
🇮🇹Firenze, Italy
Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma
🇮🇹Verona, Italy
Medical Oncology Department, General Hospital of Baza
🇪🇸Granada, Spain
Oncology Department, Clinic Universitary Hospital
🇪🇸Malaga, Spain
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
Billings Clinic
🇺🇸Billings, Montana, United States