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.
- 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
- 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