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

Cell Genesys

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Prostate Cancer

Treatments

Biological: CG7870

Study type

Interventional

Funder types

Industry

Identifiers

NCT00103428

V-0039

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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