Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- To assess the relative efficacy of the combination of GM-CSF, Thalidomide and Docetaxel in patients with prostate cancer. [ Time Frame: during study (no data currently available) ] [ Designated as safety issue: No ]PI relocated, no data currently available
- Collect data on hormonal responses produced by GM-CSF, Thalidomide and Docetaxel. [ Time Frame: during study (no data currently available) ] [ Designated as safety issue: No ]PI relocated, no data currently available
- Evaluate safety and toxicity of the combination of GM-CSF, Thalidomide and Docetaxel for patients with hormone naïve prostate cancer. [ Time Frame: during study (no data currently available) ] [ Designated as safety issue: No ]PI relocated, no data currently available
|Study Start Date:||December 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA
fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection
Other Name: LeukineDrug: thalidomide
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.
Other Name: ThalomidDrug: docetaxel
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.
Other Name: Taxotere
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450008
|United States, Texas|
|The Methodist Hospital Research Institute|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Amato, DO||The Methodist Hospital Research Institute|