Hormone-refractory Prostate CancerPhase 2NCT00201357
An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
A Phase 2 study testing Thalidomide (THADO) in people with Hormone-refractory Prostate Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-refractory Prostate Cancer
- What is being tested?
- Thalidomide (THADO)
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2002to Jul 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Hormone-refractory Prostate Cancer
- Being tested
- Thalidomide (THADO)
- Keywords
- hormone-refractory prostate cancer, thalidomide, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide (THADO)Drug
patients who receive thalidomide (100 mg BID).
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks
Measured: The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks
Secondary outcomes (1)
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.
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
Measured: The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-refractory Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruey-kuen Hsieh, M.D., Principal investigator, Taiwan cooperative oncology group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201357
- Sponsor's protocol ID
- T1802
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00201357
- Acronym / sponsor ID
- T1802
- Conditions
- Hormone-refractory Prostate Cancer
- Keywords
- hormone-refractory prostate cancer, thalidomide, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide (THADO)patients who receive thalidomide (100 mg BID). | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruey-kuen Hsieh, M.D. principal investigator
Taiwan cooperative oncology group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide (THADO) in people with Hormone-refractory Prostate Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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). (time frame: The primary objective is to determine the proportion of patients who have 50% decrease in PSA maintained for at least 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.