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

March 23, 2016 updated by: National Health Research Institutes, Taiwan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks
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

Outcome Measure
Measure Description
Time Frame
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
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
The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Investigators

  • Principal Investigator: Ruey-kuen Hsieh, M.D., Taiwan cooperative oncology group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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