Prostate CancerPhase 2NCT00046826
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
A Phase 2 study testing docetaxel, estramustine phosphate sodium and thalidomide in people with Prostate Cancer, run by Nuvance Health at 2 sites in United States.
Trial summary
RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel, estramustine phosphate sodium and thalidomide
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Sep 2001to Oct 2009
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Prior treatment with androgen ablation including:
- Orchiectomy OR
- Luteinizing hormone-releasing hormone (LHRH) therapy (e.g., leuprolide)
- Patients on leuprolide must continue to receive the drug
- Prior nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide) required
- Metastatic disease with disease progression during androgen ablation, defined by at least 1 of the following:
- 2 consecutive increased prostate-specific antigen (PSA) levels measured at least 1 week apart
- More than 25% increase in bidimensionally measurable soft tissue metastases
- 20% increase in the sum of the baseline sum of longest diameter of measurable lesions
- Appearance of new lesions
- Appearance of new foci on a radionuclide bone scan
- PSA greater than 10 ng/dL
- Testosterone no greater than 50 ng/mL (castrate level)
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 16 weeks
Hematopoietic:
- WBC greater than 3,500/mm3
- Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin at least 8 g/dL
Hepatic:
- AST and/or ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
- Alkaline phosphatase no greater than 4 times ULN if AST/ALT no greater than ULN
- Bilirubin no greater than ULN
Renal:
- Creatinine less than 2.2 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart disease
- No history of arterial or venous thrombosis
- No cerebrovascular accident within the past year
Pulmonary:
- No history of pulmonary embolism
Other:
- Fertile patients must use effective contraception during and for 4 weeks after study
- No peripheral neuropathy grade 2 or greater
- No active infection
- No serious concurrent medical illness that would preclude study
- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No other prior or concurrent active malignancy within the past 2 years except non-melanoma skin cancers
- No other medical condition or reason that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for prostate cancer
Endocrine therapy:
- See Disease Characteristics
- At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and continued evidence of disease progression (rising PSA)
- Prior steroids for prostate cancer allowed
- No concurrent steroids except for pre-medication for docetaxel
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No concurrent herbal supplements to treat prostate cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Whittingham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, 06856
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
Stamford, Connecticut, 06904
About this study
Official title: A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer
RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel, estramustine, and thalidomide.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the efficacy of this regimen for pain control in these patients.
OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, estramustine phosphate sodium, thalidomide
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
estramustine phosphate sodiumDrug
thalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment
Secondary outcomes (2)
Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit
Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2001
- Primary completionJun 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Nuvance Health
- Sponsor type
- University, hospital or other
- Investigators
- Richard C. Frank, MD, Study chair, Nuvance Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046826
- Sponsor's protocol ID
- CDR0000069081
- Other IDs
- NH-0139, NCI-V01-1681
- Status last verified
- Jan 2006
- First submitted
- 3 Oct 2002
- Last updated
- 4 Apr 2013
- Results posted
- No
Publications
Frank RC, Coscia A, Versea L, et al.: Low dose docetaxel, estramustine and thalidomide followed by maintenance thalidomide for the treatment of hormone refractory prostate cancer (HRPC): a phase II community based trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4681, 426s, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00046826
- Acronym / sponsor ID
- CDR0000069081
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Nuvance HealthUniversity, hospital or other
- Study start
- Sep 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy.
Detailed description
OBJECTIVES:
- Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel, estramustine, and thalidomide.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the efficacy of this regimen for pain control in these patients.
OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| docetaxel | Drug | – |
| estramustine phosphate sodium | Drug | – |
| thalidomide | Drug | – |
Primary outcome
Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment
2 secondary outcomes
Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit
Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit
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 4 Apr 2013.
- Results publicationFrank RC, Coscia A, Versea L, et al.: Low dose docetaxel, estramustine and thalidomide followed by maintenance thalidomide for the treatment of hormone refractory prostate cancer (HRPC): a phase II community based trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4681, 426s, 2004.
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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.
Richard C. Frank, MD study chair
Nuvance Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, estramustine phosphate sodium and thalidomide in people with Prostate Cancer, run by Nuvance Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046826, which also lists 1 linked publication.
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 4 Apr 2013.