Hormone Resistant Prostate CancerPhase 2NCT00541281
Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic Cancer
A Phase 2 study testing docetaxel, estramustine and prednisone in people with Hormone Resistant Prostate Cancer and Metastatic Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 19 sites in 2 countries.
Trial summary
we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Resistant Prostate Cancer, Metastatic Prostate Cancer
- What is being tested?
- docetaxel, estramustine and prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Dec 2003to Feb 2006
- 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
- Signed informed consent prior to beginning protocol specific procedures.
- 18 years
- Histologically/cytologically proven prostate adenocarcinoma.
- Documented metastatic prostate adenocarcinoma
- Patients must have received prior hormonal therapy as defined below:
- Castration by orchiectomy and/or LHRH agonists with or without
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- Antiandrogens
- Other hormonal agents (e.g., ketoconazole, ...)
- Testosterone level should be < 50 ng/dl in all patients (castrated level).
- Respect of antiandrogen withdrawal period
- No prior chemotherapy regimen at the exception of estramustine phosphate.
- documented disease progression defined either (i) by PSA increase and/or (ii) imaging:
- Prior radiation therapy (to less or equal than 25% of the bone marrow only) is allowed. At least 4 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects.
- Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery.
- Life expectancy > 3 months.
- ECOG performance status 0-2.
- Normal cardiac function.
Who cannot join
- Prior chemotherapy except estramustine phosphate.(2)
- Prior isotope therapy
- Prior radiotherapy to >25% of bone marrow
- Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.
- Known brain or leptomeningeal involvement.
- Symptomatic peripheral neuropathy > grade 2
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- Other serious illness or medical condition
- Concurrent treatment with other experimental drugs.
- Treatment with any other anti-cancer therapy (except LHRH agonists)
- Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped prior to the administration of docetaxel.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Belgium18 sites
RHMS louis caty
Baudour, 7331
Clinique Saint Luc
Bouge, 5004
CHR Warquignies
Boussu, 7300
Az klina
Brasschaat, 2930
Parc Léopold
Brussels, 1040
Hôpitaux IRIS Sud
Brussels, 1050
Cliniques Universitaires St luc
Brussels, 1200
Notre Dame et Reine Fabiola
Charleroi, Hainaut, 6000
Sint Nilolaus
Eupen, 4700
Clinique St Joseph
Gilly, 6000
Notre Dame de Grâce
Gosselies, 6041
CH Jolimont Lobbes
La Louvière, 7100
St Joseph
Liège, 4000
CHU Ambroise paré
Mons, 7000
clinique Sainte Elisabeth
Namur, 5000
St Pierre
Ottignies, Brabant Wallon, 1340
Notre Dame
Tournai, 7500
Clinique Universitaire de Mt Godinne
Yvoir, 5004
About this study
Official title: Randomized Phase Ii Trial Of Weekly Docetaxel, Estramustine And Prednisone Versus Docetaxel And Prednisone In Patient With Hormone-Resistant Prostate Cancer
we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response.
Read the detailed description
The addition of estramustine to other chemotherapeutic agents that affect microtubule function may improve their efficacy15, 16, 17, 18. A phase III trial compared vinblastine versus the combination of vinblastine plus estramustine as treatment for patients with hormone-refractory prostate cancer. They showed that the association of estramustine and vinblastine was superior to vinblastine alone for time to progression, PSA response and survival (Hudes et al., ASCO 2002). In addition, Berry et al. found that estramustine/paclitaxel improved PSA response rate but not overall survival compared with paclitaxel alone (Berry et al. ASCO2001).
Similar association has been studied with docetaxel. In a phase I trial combining docetaxel and estramustine19, 53% of patients reported a decrease in narcotic use and 63% experienced a PSA response. In another phase I trial, a reduction in PSA of 50% or more was observed in 14 of 17 patients (82%)20. In a phase II trial involving 35 patients, a PSA response was reported in 74% of the patients and objective response in 4 out of 7 patients with measurable disease21. Median survival 22 months in this last study. These studies as well as other support the combination of estramustine and docetaxel in the treatment of HRPC22, 23.
Recently, Oudard et al. competed a phase II randomized study comparing mitoxantrone/prednisone versus docetaxel/estramustine prednisone24. Docetaxel was given either weekly or every 3 weeks. Association of docetaxel/estramustine was found superior to mitoxantrone in term of PSA response, (67-63% versus 18%), clinical benefit (79-56% versus 41%) and survival (19.2 months versus 11.6 months). In addition, toxicities of these regimens were manageable and predictable. In this study, patients received 2 mgr of coumadin to prevent thromboembolic event due to estramustine and only 7 % of the patients had thrombosis. Other grade III \& IV toxicities of the estramustine/docetaxel combination included neutropenia (37% in the 3-week regimen and 0 % in the weekly regimen) nausea/vomiting (2% in the 3-week regimen and 0 % in the weekly regimen), diarrhea (7% in the 3-week regimen and 0 % in the weekly regimen). No febrile neutropenia was observed.
Although these data support a role for chemotherapy combinations, such as estramustine and docetaxel, in the treatment of HRPC, further studies are needed to determine the relative contribution of estramustine to the efficacy of docetaxel/estramustine regimen. In this context, we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response. We chose to use the weekly regimen as described by Oudard since the toxicity of this regimen is well described and is easily manageable in our experience.
- Being tested
- docetaxel, estramustine, prednisone
- Keywords
- prostate cancer, hormone resistant, metastatic, estramustine combine to docetaxel, randomized study
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called Taxotere
35mg/m² on day 2 and 9 (21days in a cycle)
estramustineDrug
Also called estramustine phosphate
140mg caps x3 bid from day 1to 5 and day 8 to 12 of each cycle
prednisoneDrug
Also called medrol
2x5 mg a day
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | weekly docetaxel and prednisone Receives: Drug: docetaxel; Drug: estramustine; Drug: prednisone |
| B | Active comparator | weekly docetaxel (35mg/m\&) plus prednisone 10mg a day associated with estramustine form day 1to 5 and 8 to 12 Receives: Drug: docetaxel; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of the association of Docetaxel and Estramustineand Prednisone versus Docetaxel and Prednisone in the treatment of hormone refractory prostate cancer in terms o PSA response
Measured: within 30 days after end of treatment
Secondary outcomes (1)
PSA response Time to PSA progression PSA response duration Event Progression-Free Survival Overall survival Palliative response (Pain) Safety Objective response measurable disease (RECIST)
Measured: untill death occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startDec 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Jean-Pascal Machiels, MD PHD, Principal investigator, Cliniques Universitaires St LucJoseph Kerger, MD, Principal investigator, Clinqiue Universitaire de Mont Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541281
- Sponsor's protocol ID
- UCL-ONCO 04-001
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2007
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase Ii Trial Of Weekly Docetaxel, Estramustine And Prednisone Versus Docetaxel And Prednisone In Patient With Hormone-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00541281
- Acronym / sponsor ID
- UCL-ONCO 04-001
- Keywords
- prostate cancer, hormone resistant, metastatic, estramustine combine to docetaxel, randomized study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2003
- Study completion
- Feb 2006 (actual)
- First posted
- 10 Oct 2007 (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.
we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response.
Detailed description
The addition of estramustine to other chemotherapeutic agents that affect microtubule function may improve their efficacy15, 16, 17, 18. A phase III trial compared vinblastine versus the combination of vinblastine plus estramustine as treatment for patients with hormone-refractory prostate cancer. They showed that the association of estramustine and vinblastine was superior to vinblastine alone for time to progression, PSA response and survival (Hudes et al., ASCO 2002). In addition, Berry et al. found that estramustine/paclitaxel improved PSA response rate but not overall survival compared with paclitaxel alone (Berry et al. ASCO2001).
Similar association has been studied with docetaxel. In a phase I trial combining docetaxel and estramustine19, 53% of patients reported a decrease in narcotic use and 63% experienced a PSA response. In another phase I trial, a reduction in PSA of 50% or more was observed in 14 of 17 patients (82%)20. In a phase II trial involving 35 patients, a PSA response was reported in 74% of the patients and objective response in 4 out of 7 patients with measurable disease21. Median survival 22 months in this last study. These studies as well as other support the combination of estramustine and docetaxel in the treatment of HRPC22, 23.
Recently, Oudard et al. competed a phase II randomized study comparing mitoxantrone/prednisone versus docetaxel/estramustine prednisone24. Docetaxel was given either weekly or every 3 weeks. Association of docetaxel/estramustine was found superior to mitoxantrone in term of PSA response, (67-63% versus 18%), clinical benefit (79-56% versus 41%) and survival (19.2 months versus 11.6 months). In addition, toxicities of these regimens were manageable and predictable. In this study, patients received 2 mgr of coumadin to prevent thromboembolic event due to estramustine and only 7 % of the patients had thrombosis. Other grade III \& IV toxicities of the estramustine/docetaxel combination included neutropenia (37% in the 3-week regimen and 0 % in the weekly regimen) nausea/vomiting (2% in the 3-week regimen and 0 % in the weekly regimen), diarrhea (7% in the 3-week regimen and 0 % in the weekly regimen). No febrile neutropenia was observed.
Although these data support a role for chemotherapy combinations, such as estramustine and docetaxel, in the treatment of HRPC, further studies are needed to determine the relative contribution of estramustine to the efficacy of docetaxel/estramustine regimen. In this context, we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response. We chose to use the weekly regimen as described by Oudard since the toxicity of this regimen is well described and is easily manageable in our experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: docetaxel, Drug: estramustine, Drug: prednisoneweekly docetaxel and prednisone |
| B | Active comparator | Drug: docetaxel, Drug: prednisoneweekly docetaxel (35mg/m\&) plus prednisone 10mg a day associated with estramustine form day 1to 5 and 8 to 12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed informed consent prior to beginning protocol specific procedures.
- 18 years
- Histologically/cytologically proven prostate adenocarcinoma.
- Documented metastatic prostate adenocarcinoma
- Patients must have received prior hormonal therapy as defined below:
Key exclusion criteria (10 listed)
- Prior chemotherapy except estramustine phosphate.(2)
- Prior isotope therapy
- Prior radiotherapy to >25% of bone marrow
- Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.
- Known brain or leptomeningeal involvement.
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 |
|---|---|---|
| docetaxelAlso: Taxotere35mg/m² on day 2 and 9 (21days in a cycle) | Drug | A, B |
| estramustineAlso: estramustine phosphate140mg caps x3 bid from day 1to 5 and day 8 to 12 of each cycle | Drug | A |
| prednisoneAlso: medrol2x5 mg a day | Drug | A, B |
Primary outcome
To compare the efficacy of the association of Docetaxel and Estramustineand Prednisone versus Docetaxel and Prednisone in the treatment of hormone refractory prostate cancer in terms o PSA response
Time frame: within 30 days after end of treatment
1 secondary outcome
PSA response Time to PSA progression PSA response duration Event Progression-Free Survival Overall survival Palliative response (Pain) Safety Objective response measurable disease (RECIST)
Time frame: untill death occurs
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 27 Oct 2009.
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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.
Jean-Pascal Machiels, MD PHD principal investigator
Cliniques Universitaires St Luc
Joseph Kerger, MD principal investigator
Clinqiue Universitaire de Mont Godinne
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, estramustine and prednisone in people with Hormone Resistant Prostate Cancer and Metastatic Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 19 sites in 2 countries.
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 17 inclusion and 10 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 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Belgium, Luxembourg. 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 compare the efficacy of the association of Docetaxel and Estramustineand Prednisone versus Docetaxel and Prednisone in the treatment of hormone refractory prostate cancer in terms o PSA response (time frame: within 30 days after end of treatment). 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 27 Oct 2009.