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An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
Mackay Memorial Hospital
Tri-Service General Hospital
China Medical University Hospital
Chi Mei Medical Hospital
Buddhist Tzu Chi General Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201357
First received: September 13, 2005
Last updated: April 2, 2009
Last verified: September 2005

September 13, 2005
April 2, 2009
November 2002
Not Provided
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).
Same as current
Complete list of historical versions of study NCT00201357 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

  • 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
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormone-Refractory Prostate Cancer
Drug: Thalidomide (THADO)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2004
Not Provided

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00201357
T1802
Not Provided
Not Provided
National Health Research Institutes, Taiwan
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital, Taiwan
  • Chang Gung Memorial Hospital
  • Mackay Memorial Hospital
  • Tri-Service General Hospital
  • China Medical University Hospital
  • Chi Mei Medical Hospital
  • Buddhist Tzu Chi General Hospital
Principal Investigator: Ruey-kuen Hsieh, M.D. Taiwan cooperative oncology group
National Health Research Institutes, Taiwan
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP