Prostate Cancer
Conditions
Keywords
chemotherapy, prostate cancer, cancer, metastatic, hormone refractory, chemotherapy naive, dose escalation
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. 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.
Interventions
BIOLOGICALCG7870
Sponsors
Cell Genesys
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metastatic hormone refractory prostate cancer | — |
Countries
United States
Outcome results
None listed