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

NCT00103428 | Terminated Phase 1

• 1 other identifier: V-0039
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

chemotherapy; prostate cancer; cancer; metastatic; hormone refractory; chemotherapy naive; dose escalation

Outcome Measures

Primary Outcomes (1)

• Metastatic hormone refractory prostate cancer

Interventions

CG7870 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cell Genesys: lead

Study Sites (1)

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2005
• First Posted: February 9, 2005
• Study Start: August 1, 2004
• Last Updated: February 2, 2006

Record last verified: 2006-01

Locations

US (1)