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

Sponsor
Pharmexa A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT00358566
Collaborator
ICON Clinical Research (Industry), ORION Clinical Services (Industry), CIRION Central Laboratory (Other), Dorevitch (Other), Syneos Health (Other)
360
Enrollment
86
Locations
2
Arms
26
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: GV1001
  • Drug: Gemcitabine (Chemotherapy)
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
Study Start Date :
Jun 1, 2006
Anticipated Primary Completion Date :
Aug 1, 2008
Anticipated Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Gemcitabine

Gemcitabine alone treatment.

Drug: Gemcitabine (Chemotherapy)
Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.
Other Names:
  • Gemzar

    		•
    Experimental: GV1001

    GV1001 in sequential combination with Gemcitabine

    Biological: GV1001
    0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.
    Other Names:
  • INN-name: Termotide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival time [12 month]

    Secondary Outcome Measures

    1. Progression Free Survival [Time of progression]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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]

    1. 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

    1. Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L].

    2. Performance status ECOG 0-1.

    3. Male or female 18 - 75 years inclusive.

    4. Minimum life expectancy of 3 months.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36688
    2 Genesis Cancer Center Hot Springs Arkansas United States 71913
    3 Scripps Clinic Torrey Pines La Jolla California United States 92037
    4 Desert Hematology Oncology Medical Group, Inc. Rancho Mirage California United States 92270
    5 The Center for Hematology-Oncology Boca Raton Florida United States 33486
    6 Tampa General Hospital Usf Digestive Disorders Centre Tampa Florida United States 33606
    7 Palm Beach Cancer Institute West Palm Beach Florida United States 33401
    8 Portneuf Cancer Center Pocatello Idaho United States 83204
    9 Oncology Hematology Associates of Central Illinois, PC Peoria Illinois United States 61615
    10 Hematology Oncology Specialists, Covington Covington Louisiana United States 70433
    11 Berskhire Hematology Oncology PC Pittsfield Massachusetts United States 01201
    12 Billings Clinic Billings Montana United States 59101
    13 Carolinas Hematology Oncology Associates Charlotte North Carolina United States 28203
    14 Gabrail Cancer Center Canton Ohio United States 44718
    15 Toledo Community Hospital Oncology Program Toledo Ohio United States 43617
    16 Southwest Regional Cancer Center Austin Texas United States 78705
    17 Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas Dallas Texas United States 75231
    18 Mary Crowley Medical Research Center, Worth St. Dallas Texas United States 75249
    19 Oncology Consultants, PA Houston Texas United States 77024
    20 St George Hospital, Department of Medical Oncology Kogarah New South Wales Australia NSW 2217
    21 Westmead Hospital, Dept. of Medical Oncology and Palliative Care Westmead New South Wales Australia NSW 2145
    22 The Townsville Hospital, Townsville Cancer Centre Douglas Queensland Australia QLD 4814
    23 Flinders Medical Centre, Medical Oncology - Clinical Trials Bedford Park South Australia Australia SA 5042
    24 Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital Woodville South South Australia Australia
    25 Royal Hobart Hospital, Centre for Clinical Research Hobart Tasmania Australia TAS 7000
    26 Box Hill Hospital, ECRU Oncology Box Hill Victoria Australia VIC 3128
    27 The Alfred Hospital, Medical Oncology Unit Melbourne Victoria Australia VIC 3004
    28 Fremantle Hospital, Haemtology Department Fremantle Western Australia Australia WA 6160
    29 Sir Charles Gairdner Hospital Nedlands Western Australia Australia
    30 Mount Medical Centre, Perth Oncology Perth Western Australia Australia WA 6000
    31 Royal Perth Hospital, Department of Medical Oncology Perth Western Australia Australia WA 6000
    32 Wesley Research Institute Limited Auchenflower Qld Australia
    33 Erasms University Hospital Brussels Belgium 1070
    34 Hospital De Jolimont Bruxelles Belgium 7100
    35 Ghent University Hospital, Digestive Oncology Ghent Belgium 9000
    36 Oncology Department, Herlev Hospital Herlev Denmark
    37 Odense Universitetshospital, Onkologisk afd. R Odense Denmark 5000
    38 Oncology Department, Århus Hospital Århus Denmark
    39 Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin Angers Cedex 01 France 49933
    40 Oncologie Medicale, Clinic Pasteur Evreux France 27000
    41 Hepatogastroenterology Dpt, University Hospital Center of Grenoble Grenoble Cedex France
    42 Service de Medicine Interne, CHRU de Lille Lille France 59037
    43 Oncologie Midicale CHR Lorient Lorient France 56100
    44 Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale Moreau France 85925
    45 Oncologie Médicale, Centre Cathrine de Siennes Nantes France 44200
    46 Service de Cancerologie, Hospital Europeen Georges Pompidou Paris France 75015
    47 Medical Oncology Dpt, Armoricaine Private Hospital of Radiology Saint Brieuc France
    48 Clinic Saint Vincent Saint Gregoire France 35760
    49 Oncology Trials Unit, Cork University Hospital Cork Ireland
    50 Cancer Clinical Trials Unit, Beaumont Hospital Dublin Ireland
    51 Cancer Research Unit, Mater Misericordlae University Hospital Dublin Ireland
    52 Department of Medical Oncology, Amnch Dublin Ireland
    53 Oncology Research Team, Mater Private University Hospital Dublin Ireland
    54 Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita Ancona Italy 60100
    55 Policlinico Universitario "Mater Domini", Unita Oncologia Catanzaro Italy 88100
    56 Hospital "Careggi", Medical Oncology Firenze Italy 50139
    57 Azienda Ospedaliera, Arcispedale S. Maria Nuova Reggio Emilia Italy 42100
    58 Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma Verona Italy 37134
    59 VU University Medical Center Amsterdam Netherlands 1081 HV
    60 Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology Bergen Norway
    61 Sorlandet Hospital, Senter for Kreftbehandling Kristiansand Norway 4604
    62 Ullevål Universitetssykehus, Gastrokirurgisk afd. Oslo Norway 0407
    63 Department of Oncology, University Hospital of Northern-Norway Tromsoe Norway
    64 Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych Bialystok Poland 15-027
    65 W.S2.Z, Krolewiecka Elblag Poland 82-300
    66 Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii Krakow Poland 31-826
    67 Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University Lodz Poland
    68 Zaklad Opieki Zdrowotnej MSWiA Olsztyn Poland 10-228
    69 Centrum Onkologii, Wosewodzki Osrodek Onkologii Opole Poland 45-060
    70 Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii Wroclaw Poland 53-143
    71 Hospital Clinic I Provincial De Barcelona Barcelona Spain 08036
    72 Medical Oncology Department, General Hospital of Baza Granada Spain
    73 Medical Oncology Department, Virgen de Las Nieves Hospital Granada Spain
    74 Hospital Universitario Gregorio Marañón, Departamento de Oncología Madrid Spain 28007
    75 Clínica Puerta de Hierro, Departamento de Oncología Madrid Spain 28035
    76 Hospital Universitario La Paz, Departamento de Oncología Madrid Spain 28046
    77 H. Monteprincipe Madrid Spain 28660
    78 Fundaciόn Hospital de Alcorcόn, Unidad de Oncología Madrid Spain 28922
    79 HRU Carlos Haya, Medical Oncology Unit Malaga Spain 29010
    80 Oncology Department, Clinic Universitary Hospital Malaga Spain
    81 Digestive Unit, Universitary Hospital Virgen de La Macarena Seville Spain
    82 Sahlgrenska Hospital, Head Division for Upper GI Surgery Goteborg Sweden 413 45
    83 University Hospital, Department Of surgery and Gasterenterology Lund Sweden 221 85
    84 Department of Oncology, Malmö University Hospital Malmö Sweden
    85 Karolinska Institute / Hospital Solna, Department of Oncology Stockholm Sweden 171 76
    86 Department of Oncology, Karolinska Universitetssjukhuset Stockholm Sweden SE- 171 76

    Sponsors and Collaborators

    • Pharmexa A/S
    • ICON Clinical Research
    • ORION Clinical Services
    • CIRION Central Laboratory
    • Dorevitch
    • Syneos Health

    Investigators

    • Study Director: Ask Aabenhus, MSc. (Pharm), Pharmexa A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00358566
    Other Study ID Numbers:
    • PX115.1.1-302
    • Eudract no. 2005-005014-21
    First Posted:
    Aug 1, 2006
    Last Update Posted:
    May 19, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    Advanced
    Unresesctable
    Adenocarcinoma
    Pancreatic cancer
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of May 19, 2008