Clinical trial NCT00358566: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Advanced Unresectable Pancreatic Cancer
Keywords: Advanced
Unresesctable
Adenocarcinoma
Pancreatic cancer
Lead sponsor: Pharmexa A/S
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
name: ORION Clinical Services
name: CIRION Central Laboratory
name: Dorevitch
name: Syneos Health
First posted: 2006-08-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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) \</= 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.

Primary outcomes:
measure: Overall survival time
timeFrame: 12 month
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Time of progression
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: Boca Raton
country: United States
facility: The Center for Hematology-Oncology
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital Usf Digestive Disorders Centre
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Pocatello
country: United States
facility: Portneuf Cancer Center
state: Idaho
city: Peoria
country: United States
facility: Oncology Hematology Associates of Central Illinois, PC
state: Illinois
city: Covington
country: United States
facility: Hematology Oncology Specialists, Covington
state: Louisiana
city: Pittsfield
country: United States
facility: Berskhire Hematology Oncology PC
state: Massachusetts
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Charlotte
country: United States
facility: Carolinas Hematology Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Community Hospital Oncology Program
state: Ohio
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center, Worth St.
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, PA
state: Texas
city: Kogarah
country: Australia
facility: St George Hospital, Department of Medical Oncology
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital, Dept. of Medical Oncology and Palliative Care
state: New South Wales
city: Douglas
country: Australia
facility: The Townsville Hospital, Townsville Cancer Centre
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre, Medical Oncology - Clinical Trials
state: South Australia
city: Woodville South
country: Australia
facility: Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital, Centre for Clinical Research
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital, ECRU Oncology
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital, Medical Oncology Unit
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital, Haemtology Department
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Mount Medical Centre, Perth Oncology
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital, Department of Medical Oncology
state: Western Australia
city: Auchenflower Qld
country: Australia
facility: Wesley Research Institute Limited
city: Brussels
country: Belgium
facility: Erasms University Hospital
city: Bruxelles
country: Belgium
facility: Hospital De Jolimont
city: Ghent
country: Belgium
facility: Ghent University Hospital, Digestive Oncology
city: Herlev
country: Denmark
facility: Oncology Department, Herlev Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital, Onkologisk afd. R
city: Århus
country: Denmark
facility: Oncology Department, Århus Hospital
city: Angers Cedex 01
country: France
facility: Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin
city: Evreux
country: France
facility: Oncologie Medicale, Clinic Pasteur
city: Grenoble Cedex
country: France
facility: Hepatogastroenterology Dpt, University Hospital Center of Grenoble
city: Lille
country: France
facility: Service de Medicine Interne, CHRU de Lille
city: Lorient
country: France
facility: Oncologie Midicale CHR Lorient
city: Moreau
country: France
facility: Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale
city: Nantes
country: France
facility: Oncologie Médicale, Centre Cathrine de Siennes
city: Paris
country: France
facility: Service de Cancerologie, Hospital Europeen Georges Pompidou
city: Saint Brieuc
country: France
facility: Medical Oncology Dpt, Armoricaine Private Hospital of Radiology
city: Saint Gregoire
country: France
facility: Clinic Saint Vincent
city: Cork
country: Ireland
facility: Oncology Trials Unit, Cork University Hospital
city: Dublin
country: Ireland
facility: Cancer Clinical Trials Unit, Beaumont Hospital
city: Dublin
country: Ireland
facility: Cancer Research Unit, Mater Misericordlae University Hospital
city: Dublin
country: Ireland
facility: Department of Medical Oncology, Amnch
city: Dublin
country: Ireland
facility: Oncology Research Team, Mater Private University Hospital
city: Ancona
country: Italy
facility: Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita
city: Catanzaro
country: Italy
facility: Policlinico Universitario "Mater Domini", Unita Oncologia
city: Firenze
country: Italy
facility: Hospital "Careggi", Medical Oncology
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera, Arcispedale S. Maria Nuova
city: Verona
country: Italy
facility: Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Bergen
country: Norway
facility: Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology
city: Kristiansand
country: Norway
facility: Sorlandet Hospital, Senter for Kreftbehandling
city: Oslo
country: Norway
facility: Ullevål Universitetssykehus, Gastrokirurgisk afd.
city: Tromsoe
country: Norway
facility: Department of Oncology, University Hospital of Northern-Norway
city: Bialystok
country: Poland
facility: Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych
city: Elblag
country: Poland
facility: W.S2.Z, Krolewiecka
city: Krakow
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii
city: Lodz
country: Poland
facility: Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University
city: Olsztyn
country: Poland
facility: Zaklad Opieki Zdrowotnej MSWiA
city: Opole
country: Poland
facility: Centrum Onkologii, Wosewodzki Osrodek Onkologii
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial De Barcelona
city: Granada
country: Spain
facility: Medical Oncology Department, General Hospital of Baza
city: Granada
country: Spain
facility: Medical Oncology Department, Virgen de Las Nieves Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón, Departamento de Oncología
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro, Departamento de Oncología
city: Madrid
country: Spain
facility: Hospital Universitario La Paz, Departamento de Oncología
city: Madrid
country: Spain
facility: H. Monteprincipe
city: Madrid
country: Spain
facility: Fundaciόn Hospital de Alcorcόn, Unidad de Oncología
city: Malaga
country: Spain
facility: HRU Carlos Haya, Medical Oncology Unit
city: Malaga
country: Spain
facility: Oncology Department, Clinic Universitary Hospital
city: Seville
country: Spain
facility: Digestive Unit, Universitary Hospital Virgen de La Macarena
city: Goteborg
country: Sweden
facility: Sahlgrenska Hospital, Head Division for Upper GI Surgery
city: Lund
country: Sweden
facility: University Hospital, Department Of surgery and Gasterenterology
city: Malmö
country: Sweden
facility: Department of Oncology, Malmö University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institute / Hospital Solna, Department of Oncology
city: Stockholm
country: Sweden
facility: Department of Oncology, Karolinska Universitetssjukhuset
Study officials:
affiliation: Pharmexa A/S
name: Ask Aabenhus, MSc. (Pharm)
role: STUDY_DIRECTOR
References: