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

Prostate Cancer Clinical Trial

Official title:

A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00103428
• Other study ID #: V-0039
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 8, 2005
• Last updated: January 31, 2006
• Start date: August 2004

Study information

• Verified date: January 2006
• Source: Cell Genesys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• CG7870

Locations

Country	Name	City	State
United States	Mary Crowley Medical Research Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cell Genesys

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastatic hormone refractory prostate cancer