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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
  Purpose

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.


Condition Intervention Phase
Hormone-Refractory Prostate Cancer
Drug: Thalidomide (THADO)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 70
Study Start Date: November 2002
Estimated Study Completion Date: June 2004
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) 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201357

Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
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
Investigators
Principal Investigator: Ruey-kuen Hsieh, M.D. Taiwan cooperative oncology group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201357     History of Changes
Other Study ID Numbers: T1802
Study First Received: September 13, 2005
Last Updated: April 2, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
hormone-refractory prostate cancer
thalidomide
quality of life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Hormones
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014