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

Stopped early · Phase 2

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT00450008

Run by

The Methodist Hospital Research Institute

People needed

9

Starts

2006-12-01

Expected to finish

2008-09-01

Last updated by the study team

2016-03-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Methodist Hospital Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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