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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CG7870

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Locations

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Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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V-0039

Identifier Type: -

Identifier Source: org_study_id