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

This study has been terminated.

Sponsor:

Information provided by:

Cell Genesys

ClinicalTrials.gov Identifier:

NCT00103428

First received: February 8, 2005

Last updated: January 31, 2006

Last verified: January 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	February 8, 2005
Last Updated Date	January 31, 2006
Start Date ^ICMJE	August 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Metastatic hormone refractory prostate cancer
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00103428 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer
Official Title ^ICMJE	A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Biological: CG7870
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	69
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00103428
Other Study ID Numbers ^ICMJE	V-0039
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Cell Genesys
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cell Genesys
Verification Date	January 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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