The purpose of this study is to assess the relative efficacy and toxicity of combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA.
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 PSA values. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection
Thalidomide by oral administration at a fixed dose of 200 mg. Prophylactic Coumadin® by oral administration at a fixed dose of 2.5 mg to prevent thromboembolic events (DVT and TIA/stroke) during Thalidomide administration. Thalidomide and Coumadin will be given daily at bedtime without interruption.
Docetaxel will be administered by intravenous piggyback over 1 hour at 75mg/m² every 3 weeks. Pre-medication for the docetaxel infusion will consist of dexamethasone 8 mg administered orally 12 hours, 3 hours and 1 hour before docetaxel.
The Methodist Hospital Research Institute
Houston, Texas, United States
To assess the relative efficacy of the combination of GM-CSF, Thalidomide and Docetaxel in patients with prostate cancer.
PI relocated, no data currently available
Time frame: during study (no data currently available)
Collect data on hormonal responses produced by GM-CSF, Thalidomide and Docetaxel.
PI relocated, no data currently available
Time frame: during study (no data currently available)
Evaluate safety and toxicity of the combination of GM-CSF, Thalidomide and Docetaxel for patients with hormone naïve prostate cancer.
PI relocated, no data currently available
Time frame: during study (no data currently available)
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