Clinical trial · Interventional
An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
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
NCT00201357CI-TRIAL-00021513completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thalidomide (THADO) | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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).
- timeFrame
- The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks
- description
- The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks
- description
- The primary objective is to determine the proportion of patients who have the median duration of tumor response, median time to disease progression and assessments of clinical benefits, quality of life, and safety profil
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.