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TerminatedNCT00103428Updated Feb 2, 2006

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

A Phase 1/2 interventional study of CG7870 in Prostate Cancer, sponsored by Cell Genesys. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-02-02.

Sponsored by Cell Genesys · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
69
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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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Conditions studied

  • Prostate Cancer

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Keywords

  • chemotherapy
  • prostate cancer
  • cancer
  • metastatic
  • hormone refractory
  • chemotherapy naive
  • dose escalation
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In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 69 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Cell Genesys is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants

Interventions

  • BiologicalCG7870
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What researchers measure

Primary outcomes

  1. Metastatic hormone refractory prostate cancer

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Study locations

1 site
  • Mary Crowley Medical Research Center
    Dallas, Texas 75246, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00103428
Lead sponsor
Cell Genesys
First posted
Feb 9, 2005
Start date
Aug 2004
Last update
Feb 2, 2006
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

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