Adenocarcinoma of the ProstatePhase 2NCT00165399
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
A Phase 2 study testing Docetaxel, Estramustine and Casodex in people with Adenocarcinoma of the Prostate and Prostate Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.
Trial summary
The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Prostate Cancer
- What is being tested?
- Docetaxel, Estramustine and Casodex
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2004to 31 Dec 2005
- 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
- Histologically documented adenocarcinoma of the prostate
- Previous treatment with either radical prostatectomy or radiation therapy
- Post prostatectomy: PSA rising on at least two successive occasions at least two weeks apart
- Post radiation therapy alone: PSA has to be rising as documented on two successive occasions at least two weeks apart and also have doubled from the nadir post treatment value
- ECOG performance status 0-1
- ANC > 1,500/mm3
- Platelet counts > 100,000/mm3
- SGOT and/or SGPT may be up to 2.5 x ULN
Who cannot join
- Documented local recurrence of prostate cancer or documented metastatic disease
- History of other malignancy within the last 5 years, other than curatively treated basal cell carcinoma of the skin
- Medical condition requiring the use of concommitant corticosteroids
- Active infection
- Significant cardiac disease, angina pectoris or myocardial infarction within six months
- Prior chemotherapy including estramustine, suramin
Show all 9Show fewer
- Active thrombophlebitis or history of thromboembolic events in the six months preceding study treatment
- Clinically significant neuropathy
- Elevated bilirubin above ULN
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic-Burlington
Burlington, Massachusetts, 01805
Norris Cotton Cancer Center
Lebanon, New Hampshire, 037566-0002
University of Massachusetts Memorial Medical Center-University Campus
Worcester, Massachusetts, 01655
About this study
Official title: Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer.
This study will attempt to:
- stop or slow the growth of disease
- gain information about prostate cancer
- evaluate the effectiveness and side effects of the study drug
Read the detailed description
- Patients will receive two medications; docetaxel and estramustine. Estramustine will be taken orally three times daily for 5 days starting on day one. Docetaxel will be given intravenously on day 2. These two drugs will be repeated every 3 weeks for a total of 4 cycles (12 weeks).
- Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects.
- Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots.
- After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment. Three weeks after the last chemotherapy treatment, patients will start Casodex orally once daily.
- After taking Casodex for 1 week, patients will then start on Zoladex (an injection in the abdomen) every 3 months for a total of 5 injections.
- During study treatment various blood tests will be performed to watch the disease. Study treatment will stop after a total of 18 months (3 months chemotherapy and 15 months hormone therapy). A physical exam and blood tests will be performed every 3 months for 2 years, every 4 months for the third year, and then every 6 months after that.
- Conditions
- Adenocarcinoma of the Prostate, Prostate Cancer
- Being tested
- Docetaxel, Estramustine, Casodex, Zoladex
- Keywords
- Prostate cancer, PSA level, docetaxel, estramustine, hormone therapy, androgen withdrawal
- 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
Given intravenously on day 2 of four three-week cycles
EstramustineDrug
Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)
CasodexDrug
Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months
ZoladexDrug
Started one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.
Measured: 2 years
Secondary outcomes (2)
To determine the PSA response rate and duration of response
to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2004
- Primary completion31 Dec 2005
- Study completion31 Dec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
- Investigators
- Mary-Ellen Taplin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165399
- Sponsor's protocol ID
- 03-230
- Status last verified
- Jun 2018
- First submitted
- 9 Sep 2005
- Last updated
- 25 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
- ClinicalTrials.gov ID
- NCT00165399
- Acronym / sponsor ID
- 03-230
- Conditions
- Adenocarcinoma of the Prostate, Prostate Cancer
- Keywords
- Prostate cancer, PSA level, docetaxel, estramustine, hormone therapy, androgen withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2004 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 31 Dec 2005 (actual)
- First posted
- 14 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.
The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer.
This study will attempt to:
- stop or slow the growth of disease
- gain information about prostate cancer
- evaluate the effectiveness and side effects of the study drug
Detailed description
- Patients will receive two medications; docetaxel and estramustine. Estramustine will be taken orally three times daily for 5 days starting on day one. Docetaxel will be given intravenously on day 2. These two drugs will be repeated every 3 weeks for a total of 4 cycles (12 weeks).
- Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects.
- Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots.
- After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment. Three weeks after the last chemotherapy treatment, patients will start Casodex orally once daily.
- After taking Casodex for 1 week, patients will then start on Zoladex (an injection in the abdomen) every 3 months for a total of 5 injections.
- During study treatment various blood tests will be performed to watch the disease. Study treatment will stop after a total of 18 months (3 months chemotherapy and 15 months hormone therapy). A physical exam and blood tests will be performed every 3 months for 2 years, every 4 months for the third year, and then every 6 months after that.
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 (8 listed)
- Histologically documented adenocarcinoma of the prostate
- Previous treatment with either radical prostatectomy or radiation therapy
- Post prostatectomy: PSA rising on at least two successive occasions at least two weeks apart
- Post radiation therapy alone: PSA has to be rising as documented on two successive occasions at least two weeks apart and also have doubled from the nadir post treatment value
- ECOG performance status 0-1
Key exclusion criteria (9 listed)
- Documented local recurrence of prostate cancer or documented metastatic disease
- History of other malignancy within the last 5 years, other than curatively treated basal cell carcinoma of the skin
- Medical condition requiring the use of concommitant corticosteroids
- Active infection
- Significant cardiac disease, angina pectoris or myocardial infarction within six months
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 |
|---|---|---|
| DocetaxelGiven intravenously on day 2 of four three-week cycles | Drug | – |
| EstramustineTaken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles) | Drug | – |
| CasodexStarted 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months | Drug | – |
| ZoladexStarted one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections. | Drug | – |
Primary outcome
To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.
Time frame: 2 years
2 secondary outcomes
To determine the PSA response rate and duration of response
to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.
Time frame: 2 years
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 Jun 2018.
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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.
Mary-Ellen Taplin, MD principal investigator
Dana-Farber Cancer Institute
5 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 and Casodex in people with Adenocarcinoma of the Prostate and Prostate Cancer, run by Dana-Farber Cancer Institute at 5 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?
The sponsor lists 8 inclusion and 9 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy. (time frame: 2 years). 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 Jun 2018.