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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Hormone-Refractory Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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).

Principal Investigator

Ruey-kuen Hsieh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taiwan cooperative oncology group

Authority:

Taiwan: Department of Health

Study ID:

T1802

NCT ID:

NCT00201357

Start Date:

November 2002

Completion Date:

June 2004

Related Keywords:

  • Hormone-Refractory Prostate Cancer
  • hormone-refractory prostate cancer
  • thalidomide
  • quality of life
  • Prostatic Neoplasms

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