GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

Condition(s) targeted: Advanced Unresectable Pancreatic Cancer

Intervention: GV1001 (Biological); Gemcitabine (Chemotherapy) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pharmexa A/S

Official(s) and/or principal investigator(s):
Ask Aabenhus, MSc. (Pharm), Study Director, Affiliation: Pharmexa A/S

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

Official title: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Overall survival time

Secondary outcome: Progression Free Survival

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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) With liver metastases:

AST (SGOT) 4. Serum creatinine 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.

Wesley Research Institute Limited, AUCHENFLOWER QLD, Australia

Hospital De Jolimont, Bruxelles 7100, Belgium

Erasms University Hospital, Brussels 1070, Belgium

Ghent University Hospital, Digestive Oncology, Ghent 9000, Belgium

Odense Universitetshospital, Onkologisk afd. R, Odense 5000, Denmark

Oncology Department, ÅRHUS Hospital, ÅRHUS, Denmark

Oncology Department, Herlev Hospital, HERLEV, Denmark

Service de Medicine Interne, CHRU de Lille, Lille 59037, France

Service de Cancerologie, Hospital Europeen Georges Pompidou, Paris 75015, France

Oncologie Midicale CHR Lorient, Lorient 56100, France

Hôpital de la Roche / Yon <>, Centre Hospitalier Départmentale, Moreau 85925, France

Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin, Angers Cedex 01 49933, France

Oncologie Medicale, Clinic Pasteur, Evreux 27000, France

Clinic Saint Vincent, Saint Gregoire 35760, France

Oncologie Médicale, Centre Cathrine de Siennes, Nantes 44200, France

Medical Oncology Dpt, Armoricaine Private Hospital of Radiology, SAINT BRIEUC, France

Hepatogastroenterology Dpt, University Hospital Center of Grenoble, GRENOBLE CEDEX, France

Department of Medical Oncology, Amnch, DUBLIN, Ireland

Cancer Research Unit, Mater Misericordlae University Hospital, Dublin, Ireland

Oncology Research Team, Mater Private University Hospital, Dublin, Ireland

Oncology Trials Unit, Cork University Hospital, CORK, Ireland

Cancer Clinical Trials Unit, Beaumont Hospital, Dublin, Ireland

Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma, Verona 37134, Italy

Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita, Ancona 60100, Italy

Hospital "Careggi", Medical Oncology, Firenze 50139, Italy

Azienda Ospedaliera, Arcispedale S. Maria Nuova, Reggio Emilia 42100, Italy

Policlinico Universitario "Mater Domini", Unita Oncologia, Catanzaro 88100, Italy

VU University Medical Center, Amsterdam 1081 HV, Netherlands

Ullevål Universitetssykehus, Gastrokirurgisk afd., Oslo 0407, Norway

Sorlandet Hospital, Senter for Kreftbehandling, Kristiansand 4604, Norway

Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology, BERGEN, Norway

Department of Oncology, University Hospital of Northern-Norway, TROMSOE, Norway

Centrum Onkologii, Wosewodzki Osrodek Onkologii, Opole 45-060, Poland

Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii, Wroclaw 53-143, Poland

Zaklad Opieki Zdrowotnej MSWiA, Olsztyn 10-228, Poland

Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii, Krakow 31-826, Poland

Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University, Lodz, Poland

W.S2.Z, Krolewiecka, Elblag 82-300, Poland

Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych, Bialystok 15-027, Poland

H. Monteprincipe, Madrid 28660, Spain

Fundaciόn Hospital de Alcorcόn, Unidad de Oncología, Madrid 28922, Spain

Clínica Puerta de Hierro, Departamento de Oncología, Madrid 28035, Spain

Hospital Universitario La Paz, Departamento de Oncología, Madrid 28046, Spain

Hospital Clinic I Provincial De Barcelona, Barcelona 08036, Spain

HRU Carlos Haya, Medical Oncology Unit, Malaga 29010, Spain

Hospital Universitario Gregorio Marañón, Departamento de Oncología, Madrid 28007, Spain

Digestive Unit, Universitary Hospital Virgen De La Macarena, SEVILLE, Spain

Medical Oncology Department, Virgen De Las Nieves Hospital, GRANADA, Spain

Medical Oncology Department, General Hospital of Baza, GRANADA, Spain

Oncology Department, Clinic Universitary Hospital, Malaga, Spain

University Hospital, Department Of surgery and Gasterenterology, Lund 221 85, Sweden

Karolinska Institute / Hospital Solna, Department of Oncology, Stockholm 171 76, Sweden

Sahlgrenska Hospital, Head Division for Upper GI Surgery, Goteborg 413 45, Sweden

Department of Oncology, MALMÖ University Hospital, MALMÖ, Sweden

Department of Oncology, Karolinska Universitetssjukhuset, STOCKHOLM SE- 171 76, Sweden

University of South Alabama Mitchell Cancer Institute, Mobile, Alabama 36688, United States

Genesis Cancer Center, Hot Springs, Arkansas 71913, United States

Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California 92270, United States

Scripps Clinic Torrey Pines, La Jolla, California 92037, United States

Tampa General Hospital Usf Digestive Disorders Centre, Tampa, Florida 33606, United States

The Center for Hematology-Oncology, Boca Raton, Florida 33486, United States

Palm Beach Cancer Institute, West Palm Beach, Florida 33401, United States

Portneuf Cancer Center, Pocatello, Idaho 83204, United States

Oncology Hematology Associates of Central Illinois, PC, Peoria, Illinois 61615, United States

Hematology Oncology Specialists, Covington, Covington, Louisiana 70433, United States

Berskhire Hematology Oncology PC, Pittsfield, Massachusetts 01201, United States

Billings Clinic, Billings, Montana 59101, United States

Westmead Hospital, Dept. of Medical Oncology and Palliative Care, Westmead, New South Wales NSW 2145, Australia

St George Hospital, Department of Medical Oncology, Kogarah, New South Wales NSW 2217, Australia

Carolinas Hematology Oncology Associates, Charlotte, North Carolina 28203, United States

Gabrail Cancer Center, Canton, Ohio 44718, United States

Toledo Community Hospital Oncology Program, Toledo, Ohio 43617, United States

The Townsville Hospital, Townsville Cancer Centre, DOUGLAS, Queensland QLD 4814, Australia

Flinders Medical Centre, Medical Oncology - Clinical Trials, BEDFORD PARK, South Australia SA 5042, Australia

Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital, WOODVILLE SOUTH, South Australia, Australia

Royal Hobart Hospital, Centre for Clinical Research, Hobart, Tasmania TAS 7000, Australia

Oncology Consultants, PA, Houston, Texas 77024, United States

Mary Crowley Medical Research Center, Worth St., Dallas, Texas 75249, United States

Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas, Dallas, Texas 75231, United States

Southwest Regional Cancer Center, Austin, Texas 78705, United States

The Alfred Hospital, Medical Oncology Unit, Melbourne, Victoria VIC 3004, Australia

Box Hill Hospital, ECRU Oncology, Box Hill, Victoria VIC 3128, Australia

Fremantle Hospital, Haemtology Department, Fremantle, Western Australia WA 6160, Australia

Royal Perth Hospital, Department of Medical Oncology, Perth, Western Australia WA 6000, Australia

Mount Medical Centre, Perth Oncology, Perth, Western Australia WA 6000, Australia

Sir Charles Gairdner Hospital, NEDLANDS, Western Australia, Australia

Starting date: June 2006
Ending date: August 2008
Last updated: May 16, 2008