Status:
TERMINATED
Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer
Lead Sponsor:
Cell Genesys
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00103428
Start Date
August 1 2004
Last Update
February 2 2006
Active Locations (1)
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1
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246