Prostate CancerPhase 2NCT00083005
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
A Phase 2 study testing docetaxel, estramustine phosphate sodium and thalidomide in people with Prostate Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2004to Dec 2007
- 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
- Metastatic disease
- Androgen-independent disease
- Clinically progressive disease documented by at least 1 of the following parameters:
- Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart
- PSA ≥ 5.0 ng/mL
- Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)
- At least 1 new lesion on bone scan
- Progressive measurable disease
- Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3*
- Hemoglobin ≥ 7.5 g/dL* NOTE: *No transfusions within the past 2 weeks
Hepatic
- AST and ALT < 2.5 times upper limit of normal (ULN)
- Bilirubin < ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)
- Alkaline phosphatase ≤ 2.5 times ULN OR
- Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 40 mL/min
Cardiovascular
- No transient ischemic attacks or cerebrovascular accident within the past 2 years
- No myocardial infarction within the past 6 months
- No uncontrolled congestive heart failure
- No uncontrolled angina pectoris
- No thromboembolic disease
Other
- No peripheral neuropathy ≥ grade 2
- No cognitive impairment that would preclude study participation or giving informed consent
- No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma
- Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior thalidomide
Chemotherapy
- No prior docetaxel
- No prior estramustine
- No prior chemotherapy for metastatic prostate cancer
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Recovered from prior radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent complementary or alternative therapy that would interact with study drugs
- No concurrent herbal or nutritional products or dietary supplements that would interact with study drugs
- No concurrent aprepitant as secondary prophylaxis or antiemetic treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
NCI - Center for Cancer Research
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.
Read the detailed description
OBJECTIVES:
Primary
- Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thalidomide.
Secondary
- Determine the survival duration in patients treated with this regimen.
- Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen.
- Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel and/or thalidomide and clinical activity or toxicity of this regimen in these patients.
- Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen.
- Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients treated with this regimen.
- Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients.
- Determine the changes in molecular markers of angiogenesis (including, but not limited to, serum and urine vascular endothelial growth factor) in patients before and after treatment with this regimen.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30 minutes on days 2, 9, and 16, oral thalidomide once daily on days 1-28, and oral estramustine three times daily on days 1-3, 8-10, and 15-17. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 33-60 patients will be accrued for this study within 11-20 months.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, estramustine phosphate sodium, thalidomide
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV 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.
PSA response
Toxicity
Secondary outcomes (1)
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2004 (estimated)
- Study startMar 2004
- Primary completionDec 2007
- Study completionDec 2007
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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Avi S. Retter, MD, Study chair, Eastchester Center for Cancer Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083005
- Sponsor's protocol ID
- 040132
- Other IDs
- 04-C-0132, CDR0000361758
- Status last verified
- Mar 2012
- First submitted
- 14 May 2004
- Last updated
- 15 Mar 2012
- Results posted
- No
Publications
Sissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24.
PubMed 21106711
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00083005
- Acronym / sponsor ID
- 040132
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 May 2004 (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: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.
Detailed description
OBJECTIVES:
Primary
- Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thalidomide.
Secondary
- Determine the survival duration in patients treated with this regimen.
- Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen.
- Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel and/or thalidomide and clinical activity or toxicity of this regimen in these patients.
- Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen.
- Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients treated with this regimen.
- Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients.
- Determine the changes in molecular markers of angiogenesis (including, but not limited to, serum and urine vascular endothelial growth factor) in patients before and after treatment with this regimen.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30 minutes on days 2, 9, and 16, oral thalidomide once daily on days 1-28, and oral estramustine three times daily on days 1-3, 8-10, and 15-17. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 33-60 patients will be accrued for this study within 11-20 months.
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
PSA response
Toxicity
1 secondary outcome
Survival
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 15 Mar 2012.
- Background: PubMed 21106711Sissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24.
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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.
Avi S. Retter, MD study chair
Eastchester Center for Cancer Care
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 National Institutes of Health Clinical Center (CC) 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 15 Mar 2012. 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?
PSA response. The study lists 2 primary outcomes in all. 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 NCT00083005, 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 15 Mar 2012.