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Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer

This study has been terminated.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00103428
First received: February 8, 2005
Last updated: January 31, 2006
Last verified: January 2006

February 8, 2005
January 31, 2006
August 2004
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Metastatic hormone refractory prostate cancer
Same as current
Complete list of historical versions of study NCT00103428 on ClinicalTrials.gov Archive Site
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Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer
A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer

V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in metastatic hormone-refractory patients who have not received chemotherapy.

All patients will receive docetaxel. In the dose escalation phase of the study, patients will receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in Phase 1.

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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Biological: CG7870
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
69
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Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
  • Detectable metastases by bone scan, and/or CT scan, and/or MRI, and/or CXR
  • ECOG performance status 0-1

Exclusion Criteria:

  • Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  • History of deep vein thrombosis or pulmonary embolus
  • Patients taking anticoagulants (such as coumadin or Heparin). The use of aspirin while on study is acceptable.
  • History of a bleeding disorder or recent clinically significant bleeding
  • Seropositive for HIV
  • History of Hepatitis B, Hepatitis C, or chronic liver disease
  • Prior gene therapy or immunotherapy
  • Prior chemotherapy for prostate cancer
  • Radiation therapy within 4 weeks of the first treatment.
  • History of myocardial infarction within 6 months of the first treatment
  • History of cerebrovascular accident
  • History of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
  • Evidence of active prostatitis
  • Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103428
V-0039
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Cell Genesys
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Cell Genesys
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP