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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CG7870
Sponsored by
Cell Genesys
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring chemotherapy, prostate cancer, cancer, metastatic, hormone refractory, chemotherapy naive, dose escalation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Mary Crowley Medical Research Center

Outcomes

Primary Outcome Measures

Metastatic hormone refractory prostate cancer

Secondary Outcome Measures

Full Information

First Posted
February 8, 2005
Last Updated
January 31, 2006
Sponsor
Cell Genesys
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1. Study Identification

Unique Protocol Identification Number
NCT00103428
Brief Title
Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Terminated
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cell Genesys

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
chemotherapy, prostate cancer, cancer, metastatic, hormone refractory, chemotherapy naive, dose escalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
CG7870
Primary Outcome Measure Information:
Title
Metastatic hormone refractory prostate cancer

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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

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