Status:
COMPLETED
An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Hormone-refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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) p...
Detailed Description
* 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)...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Histologically or cytologically confirmed adenocarcinoma of prostate that is metastatic, hormone-refractory (confirmed by testing serum testosterone), and clinically progressive following at least one prior hormonal regimen.
- Patients must have documented progression of disease on anti-androgen withdrawal, if the patient have documented progression on previous anti-androgen therapy.
- Measurable (patient with measurable bi-dimensional disease) or evaluable disease (defined as the presence of a nonmeasurable abnormality on CT or on physical examination coupled with a PSA ³ 30).
- Karnofsky performance status ³ 60%.6. Adequate bone marrow functions: Granulocyte count 1,000/mm3, Platelets 75,000/mm3, haemoglobin 8 g/dl.
- Adequate renal and liver functions: Creatinine \< 1.5 mg/dl, Bilirubin \< 2 mg/dl, ALT/AST less than 2.5 times the upper limit of the reference range for the institute.
- Patients with chemical or clinical hypothyroidism should have their thyroid replacement prior to starting study.
- Patients must have recovered from the effect of recent surgery (at least 4 weeks apart), radiotherapy (at least 4 weeks apart).
- Patients have ability to complete Quality of Life (QoL) questionnaires.
- Patients must sign informed consent.
Exclusion
- Patients with advanced second primary malignancy.
- Patients with brain metastases.
- Patients with hypersensitivity to thalidomide.
- History of myocardial infarction within past 6 months, uncontrolled congestive heart failure or angina pectoris.
- Patients with orthostatic hypotension before therapy.
- Patients with NCI CTC grade 3 or greater peripheral neuropathy of any cause that is clinically detectable.
- Patients with active infection, including positive serology for HIV.
- Patients who have received chemotherapy before for treatment of metastases of prostate cancer, or received other investigational agents or corticosteroids within 4 weeks prior to enrollment of study.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00201357
Start Date
October 1 2002
End Date
July 1 2004
Last Update
March 25 2016
Active Locations (1)
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1
Mackay Memorial Hospital
Taipei, Taiwan, 104