AzTrials
AzTrials

Advanced Unresectable Pancreatic CancerPhase 3NCT00358566

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

A Phase 3 study testing GV1001 and Gemcitabine (Chemotherapy) in people with Advanced Unresectable Pancreatic Cancer, run by Pharmexa A/S at 86 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Unresectable Pancreatic Cancer
What is being tested?
GV1001 and Gemcitabine (Chemotherapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
86 sitesin 12 countries
Study dates
Jun 2006to Aug 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

86 sites in 12 countries.

86 sites in 12 countries

United States19 sites

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Billings Clinic

    Billings, Montana, 59101

  • The Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Carolinas Hematology Oncology Associates

    Charlotte, North Carolina, 28203

  • Hematology Oncology Specialists, Covington

    Covington, Louisiana, 70433

  • Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas

    Dallas, Texas, 75231

  • Mary Crowley Medical Research Center, Worth St.

    Dallas, Texas, 75249

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Oncology Consultants, PA

    Houston, Texas, 77024

  • Scripps Clinic Torrey Pines

    La Jolla, California, 92037

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36688

  • Oncology Hematology Associates of Central Illinois, PC

    Peoria, Illinois, 61615

  • Berskhire Hematology Oncology PC

    Pittsfield, Massachusetts, 01201

  • Portneuf Cancer Center

    Pocatello, Idaho, 83204

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270

  • Tampa General Hospital Usf Digestive Disorders Centre

    Tampa, Florida, 33606

  • Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43617

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

Other trials in United States

Australia13 sites

  • Wesley Research Institute Limited

    Auchenflower QLD

  • Flinders Medical Centre, Medical Oncology - Clinical Trials

    Bedford Park, South Australia, SA 5042

  • Box Hill Hospital, ECRU Oncology

    Box Hill, Victoria, VIC 3128

  • The Townsville Hospital, Townsville Cancer Centre

    Douglas, Queensland, QLD 4814

  • Fremantle Hospital, Haemtology Department

    Fremantle, Western Australia, WA 6160

  • Royal Hobart Hospital, Centre for Clinical Research

    Hobart, Tasmania, TAS 7000

  • St George Hospital, Department of Medical Oncology

    Kogarah, New South Wales, NSW 2217

  • The Alfred Hospital, Medical Oncology Unit

    Melbourne, Victoria, VIC 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

  • Mount Medical Centre, Perth Oncology

    Perth, Western Australia, WA 6000

  • Royal Perth Hospital, Department of Medical Oncology

    Perth, Western Australia, WA 6000

  • Westmead Hospital, Dept. of Medical Oncology and Palliative Care

    Westmead, New South Wales, NSW 2145

  • Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital

    Woodville South, South Australia

Other trials in Australia

Spain11 sites

  • Hospital Clinic I Provincial De Barcelona

    Barcelona, 08036

  • Medical Oncology Department, General Hospital of Baza

    Granada

  • Medical Oncology Department, Virgen de Las Nieves Hospital

    Granada

  • Hospital Universitario Gregorio Marañón, Departamento de Oncología

    Madrid, 28007

  • Clínica Puerta de Hierro, Departamento de Oncología

    Madrid, 28035

  • Hospital Universitario La Paz, Departamento de Oncología

    Madrid, 28046

  • H. Monteprincipe

    Madrid, 28660

  • Fundaciόn Hospital de Alcorcόn, Unidad de Oncología

    Madrid, 28922

  • HRU Carlos Haya, Medical Oncology Unit

    Málaga, 29010

  • Oncology Department, Clinic Universitary Hospital

    Málaga

  • Digestive Unit, Universitary Hospital Virgen de La Macarena

    Seville

Other trials in Spain

France10 sites

  • Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin

    Angers, 49933

  • Oncologie Medicale, Clinic Pasteur

    Évreux, 27000

  • Hepatogastroenterology Dpt, University Hospital Center of Grenoble

    Grenoble

  • Service de Medicine Interne, CHRU de Lille

    Lille, 59037

  • Oncologie Midicale CHR Lorient

    Lorient, 56100

  • Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale

    Moreau, 85925

  • Oncologie Médicale, Centre Cathrine de Siennes

    Nantes, 44200

  • Service de Cancerologie, Hospital Europeen Georges Pompidou

    Paris, 75015

  • Medical Oncology Dpt, Armoricaine Private Hospital of Radiology

    Saint-Brieuc

  • Clinic Saint Vincent

    Saint-Grégoire, 35760

Other trials in France

Poland7 sites

  • Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych

    Bialystok, 15-027

  • W.S2.Z, Krolewiecka

    Elblag, 82-300

  • Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii

    Krakow, 31-826

  • Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University

    Lodz

  • Zaklad Opieki Zdrowotnej MSWiA

    Olsztyn, 10-228

  • Centrum Onkologii, Wosewodzki Osrodek Onkologii

    Opole, 45-060

  • Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii

    Wroclaw, 53-143

Other trials in Poland

Ireland5 sites

  • Oncology Trials Unit, Cork University Hospital

    Cork

  • Cancer Clinical Trials Unit, Beaumont Hospital

    Dublin

  • Cancer Research Unit, Mater Misericordlae University Hospital

    Dublin

  • Department of Medical Oncology, Amnch

    Dublin

  • Oncology Research Team, Mater Private University Hospital

    Dublin

Other trials in Ireland

Italy5 sites

  • Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita

    Ancona, 60100

  • Policlinico Universitario "Mater Domini", Unita Oncologia

    Catanzaro, 88100

  • Hospital "Careggi", Medical Oncology

    Florence, 50139

  • Azienda Ospedaliera, Arcispedale S. Maria Nuova

    Reggio Emilia, 42100

  • Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma

    Verona, 37134

Other trials in Italy

Sweden5 sites

  • Sahlgrenska Hospital, Head Division for Upper GI Surgery

    Gothenburg, 413 45

  • University Hospital, Department Of surgery and Gasterenterology

    Lund, 221 85

  • Department of Oncology, Malmö University Hospital

    Malmö

  • Karolinska Institute / Hospital Solna, Department of Oncology

    Stockholm, 171 76

  • Department of Oncology, Karolinska Universitetssjukhuset

    Stockholm, SE- 171 76

Other trials in Sweden

Norway4 sites

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

    Bergen

  • Sorlandet Hospital, Senter for Kreftbehandling

    Kristiansand, 4604

  • Ullevål Universitetssykehus, Gastrokirurgisk afd.

    Oslo, 0407

  • Department of Oncology, University Hospital of Northern-Norway

    Tromsø

Other trials in Norway

Belgium3 sites

  • Erasms University Hospital

    Brussels, 1070

  • Hospital De Jolimont

    Brussels, 7100

  • Ghent University Hospital, Digestive Oncology

    Ghent, 9000

Other trials in Belgium

Denmark3 sites

  • Oncology Department, Århus Hospital

    Aarhus

  • Oncology Department, Herlev Hospital

    Herlev

  • Odense Universitetshospital, Onkologisk afd. R

    Odense, 5000

Other trials in Denmark

Netherlands1 site

  • VU University Medical Center

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
GV1001, Gemcitabine (Chemotherapy)
Keywords
Advanced, Unresesctable, Adenocarcinoma, Pancreatic cancer
Medical subject headings
Adenocarcinoma, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GV1001Biological

    Also called INN-name: Termotide

    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.

  • Gemcitabine (Chemotherapy)Drug

    Also called Gemzar

    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.

Study groups in NCT00358566
Study groupRoleWhat they receive
GemcitabineActive comparatorGemcitabine alone treatment.
Receives: Drug: Gemcitabine (Chemotherapy)
GV1001ExperimentalGV1001 in sequential combination with Gemcitabine
Receives: Biological: GV1001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival time

    Measured: 12 month

Secondary outcomes (1)

  1. Progression Free Survival

    Measured: Time of progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionAug 2008 (estimated)
  4. Study completionAug 2008 (estimated)

Why it stopped: Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00358566
Sponsor's protocol ID
PX115.1.1-302
Other IDs
Eudract no. 2005-005014-21
Status last verified
May 2008
First submitted
14 Jul 2006
Last updated
19 May 2008
Results posted
No
Data monitoring committee
Yes
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GV1001 and Gemcitabine (Chemotherapy) in people with Advanced Unresectable Pancreatic Cancer, run by Pharmexa A/S at 86 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Australia, Spain, France, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival time (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00358566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2008.

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