Phase II Study of Patients With Hormone-Naïve Prostate Cancer With a Rising Prostate Specific Antigen: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Thalidomide Plus Docetaxel
As more men are being diagnosed and treated for prostate cancer at an early age, the number
who experiences a rising level of prostate-specific antigen (PSA) after initial treatment is
increasing, affecting approximately 50,000 patients each year.
These three drugs are commercially available. Thalidomide is an angiogenesis inhibitor
which blocks the development of new blood vessels. GM-CSF stimulates the body's immune
response to fight cancer. Docetaxel is the most active chemotherapeutic agent in the
treatment of prostate cancer. GM-CSF and thalidomide have proven activity in suppressing
This study design offers an opportunity to add cytotoxic therapy (docetaxel) in combination
with an active pathobiologic regimen (GM-CSF plus thalidomide) to eradicate micrometastatic
disease, thus potentially offering a significant delay to clinical failure as measured by a
rise in PSA or radiographic involvement. Additionally, delays in the use of hormone therapy
has the potential to be of significant benefit.
GM-CSF will be administered at a fixed dose 3 days per week by subcutaneous injection for 12
months. Participants will receive a fixed dose of thalidomide orally at bedtime daily
without interruption for 12 months. Docetaxel will be administered intravenously over 1
hour on week 1 of every cycle (every 3 weeks) for 18 weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the relative efficacy of the combination of GM-CSF, Thalidomide and Docetaxel in patients with prostate cancer.
Robert J Amato, DO
The Methodist Hospital Research Institute
United States: Institutional Review Board
|The Methodist Hospital Research Institute||Houston, Texas 77030|