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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:
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201357
First received: September 13, 2005
Last updated: March 23, 2016
Last verified: March 2016
  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). [ Time Frame: The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks ] [ Designated as safety issue: Yes ]
    The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks


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. [ Time Frame: The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 30
Study Start Date: October 2002
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Thalidomide (THADO)
    patients who receive thalidomide (100 mg BID).
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 .Simon's optimal two-stage design will be used to allow early termination should sufficient evidence of non-effectiveness are collected. Thalidomide is considered non-effective if the proportion of PSA response is 14% or lower, and is worthy of further study if the proportion of response is 30% or higher. Controlling the risk for accepting thalidomide when it is non-effective to be at most 5% and the risk for rejecting thalidomide when it is effective to be at most 10%, this design calls for 26 patients at the first stage. If four or less PSA response is observed, then the study will be terminated. Otherwise, additional 44 patients will be entered at the second stage. The treatment will be rejected if a total of 14 or less PSA responses are observed out of 70 patients. This design has 70% chance of termination after the first stage if the true PSA response rate is 14% or lower. With 70 patients, the study will provide 95% assurance to claim that the difference between the estimated and true proportion will be within 11%.
  • 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   (Adult, Senior)
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
Investigators
Principal Investigator: Ruey-kuen Hsieh, M.D. Taiwan cooperative oncology group
  More Information

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00201357     History of Changes
Other Study ID Numbers: T1802 
Study First Received: September 13, 2005
Last Updated: March 23, 2016
Health Authority: Taiwan: Department of Health
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 09, 2016