Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009652

Trial Description

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Title

A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The primary objective of this study is to compare the duration of survival between patients
receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus
patients receiving docetaxel and prednisone treatment in patients with prostate cancer who
no longer respond to hormone therapy, who have documented metastases with pain. Patients may
have had up to one prior non-taxane chemotherapy treatment.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00009652
  •   2015/11/12
  •   2005/08/19
  •   no
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Secondary IDs

  •   NCT00133224  (ClinicalTrials.gov)
  •   G-0034  (Cell Genesys)
  •   VITAL-2 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
  •   Drug: Chemotherapy (docetaxel and prednisone)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Survival; time frame: 0

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Secondary Outcome

- Time to disease progression. Time to pain progression.; time frame: 0

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Countries of Recruitment

  •   Belgium
  •   Canada
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Poland
  •   Sweden
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

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  •   2005/07/31
  •   408
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion Criteria:

- Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the
prostate

- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy

- Detectable metastases

- ECOG performance status ≤2 (Performance status of 3 if due to bone pain)

- Any Gleason score

- Only one prior treatment with systemic chemotherapy

- No prior treatment with gene therapy

- No prior immunotherapy for prostate cancer

- Taxane naïve

- Experiencing cancer-related pain

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Exclusion Criteria

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Cell Genesys
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting stopped after recruiting started
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2015/11/10


* This entry means the parameter is not applicable or has not been set.