Status:
TERMINATED
Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Bayer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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, aff...
Eligibility Criteria
Inclusion
- Diagnosis of adenocarcinoma of the prostate.
- Failure of local treatments (surgery and/or radiation) as defined by a rising PSA; demonstrated by at least three consecutive rises in PSA by intervals of at least 4 weeks apart with an absolute change of at least 1 ng/mL. If the confirmatory PSA (third PSA) is less than the previous screening PSA value, an additional test for rising PSA will be required to document progression.
- No clinical or radiographic evidence of disease.
- The Zubrod performance status 0-1.
- Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as androgen therapy has been completed at least 1 year prior to study entry.
- Adequate hematologic function: absolute granulocytes ≥ 1500/ul, platelets ≥ 100,000/ul, hemoglobin ≥ 10 gm/100 ml within 4 weeks prior to study entry.
- Adequate hepatic function: bilirubin ≤ 1.5 mg/dl, liver enzymes ≤ 1.5 ULN within 4 weeks prior to study entry.
- Adequate renal function: creatinine ≤ 1.5 x ULN within 4 weeks prior to study entry.
- Patients treated with bisphosphonate therapy before or after study entry are eligible to continue in the study.
- Negative bone scan within 6 weeks prior to study entry.
- Negative CT scan or MRI of the abdomen and pelvis within 6 weeks prior to study entry.
- Negative chest x-ray for metastatic disease within 6 weeks prior to study entry.
- Patients must sign a written informed consent prior to treatment.
Exclusion
- Serious intercurrent medical illness including symptomatic heart disease within 6 months.
- Previous or concurrent invasive cancers other than superficial non-melanomatous skin cancer unless disease-free for at least 5 years.
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- History of thromboembolic events (deep venous thrombosis, symptomatic cerebrovascular events or pulmonary embolism), history of MI, within the last 12 months.
- History of bleeding disorders that would contraindicate Coumadin® (warfarin) including: esophageal varices and clotting factor defects
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00450008
Start Date
December 1 2006
End Date
September 1 2008
Last Update
March 17 2016
Active Locations (1)
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1
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030