Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Collaborator: Bayer
• Treatments: Docetaxel; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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