An Open, Non-Comparative Trial to Assess the Efficacy and Safety of Oral Thalidomide (THADO) in Patientswith Hormone-Refractory Prostate Cancer-A PHASE II CLINICAL TRIAL
- 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.
- Number of patient : about 70 evaluable patients
- Medication and Dose: Thalidomide (THADO 50mg/cap.) 100mg, BID.
- Duration: Continue treatment until disease progression, unacceptable toxicity or when
patient meets any off-study criteria.
- Efficacy assessments: % of patients with 50% decrease in PSA maintained for at least 4
weeks,Objective tumor response Median duration of tumor response Median time to disease
progression, Clinical benefits pain, performance status, weight
- Quality of life (evaluated by the instruments of EORTC-QLQ-C30, FACT-prostate)Safety
assessments:
- Toxicity -Adverse Event -Laboratory Test
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
Ruey-kuen Hsieh, M.D.
Principal Investigator
Taiwan cooperative oncology group
Taiwan: Department of Health
T1802
NCT00201357
November 2002
June 2004
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