An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
Participant gender:
Summary
Trial objectives: The primary objective is to determine the proportion of patients who have
50% decrease in PSA maintained for at least 4 weeks, in advanced hormone-refractory prostate
cancer (HRPC) patients who receive thalidomide (100 mg BID). Secondary objectives include the
objective tumor response rate for measurable lesions, the median duration of tumor response,
median time to disease progression and assessments of clinical benefits, quality of life, and
safety profile.