Prostatic NeoplasmsPhase 2NCT00268710
Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]
A Phase 2 study testing docetaxel in people with Prostatic Neoplasms, run by Sanofi.
Trial summary
Primary objectives: To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting. Secondary objectives: To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC To evaluate PSA response (PSA: Prostate Specific Antigen) To… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- docetaxel
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2004to Mar 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically proven prostate adenocarcinoma
- Progression or non response with previous chemotherapy regimen (excluding Taxotere®)
- Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine
- Castration levels of testosterone (<50 ng/dL )
- ECOG performance status 0-2
- Laboratory requirements :
Show all 16Show fewer
- Hematology:
- Neutrophils ≥ 1.5 x 10^9/L
- Hemoglobin > 10 g/dL (prior transfusion permitted).
- Platelets ≥ 100 x 10^9/L
- Hepatic function:
- Total bilirubin < the upper-normal limit of the institution.
- ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the institution.
- Renal function:
- Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)
- No severe or uncontrolled disease
Who cannot join
- Chemotherapy within the last 4 weeks
- Anti-androgen therapy within the last 4 weeks.
- Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for >2 years.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry.
- Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.
About this study
Official title: Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC)
Primary objectives:
- To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting.
Secondary objectives:
- To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC
- To evaluate PSA response (PSA: Prostate Specific Antigen)
- To evaluate symptomatic response
- To evaluate Quality of life
- To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
- Conditions
- Prostatic Neoplasms
- Being tested
- docetaxel
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)
Measured: During the Study Conduct
Secondary outcomes (6)
Analgesics (assessed by Pain Medication Log)
Measured: During the study conduct
PSA (PSA response and PSA progression
Measured: During the study conduct
Tumor lesion assessment,
Measured: During the study conduct
Overall survival
Measured: During the study conduct
Progression-free survival
Measured: During the study conduct
Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.
Measured: from the inform consent signed up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startFeb 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Canadian Urologic Oncology Group
- Investigators
- Monique Furlan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268710
- Sponsor's protocol ID
- XRP6976J_2503
- Status last verified
- Dec 2009
- First submitted
- 21 Dec 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC)
- ClinicalTrials.gov ID
- NCT00268710
- Acronym / sponsor ID
- XRP6976J_2503
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Canadian Urologic Oncology Group
- Study start
- Feb 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 22 Dec 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.
Primary objectives:
- To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting.
Secondary objectives:
- To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC
- To evaluate PSA response (PSA: Prostate Specific Antigen)
- To evaluate symptomatic response
- To evaluate Quality of life
- To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically/cytologically proven prostate adenocarcinoma
- Progression or non response with previous chemotherapy regimen (excluding Taxotere®)
- Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine
- Castration levels of testosterone (<50 ng/dL )
- ECOG performance status 0-2
Key exclusion criteria (6 listed)
- Chemotherapy within the last 4 weeks
- Anti-androgen therapy within the last 4 weeks.
- Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for >2 years.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry.
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 | – |
Primary outcome
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)
Time frame: During the Study Conduct
6 secondary outcomes
Analgesics (assessed by Pain Medication Log)
Time frame: During the study conduct
PSA (PSA response and PSA progression
Time frame: During the study conduct
Tumor lesion assessment,
Time frame: During the study conduct
Overall survival
Time frame: During the study conduct
Progression-free survival
Time frame: During the study conduct
Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.
Time frame: from the inform consent signed up to the end of the study
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 7 Dec 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.
Monique Furlan study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel in people with Prostatic Neoplasms, run by Sanofi.
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 16 inclusion and 6 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 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire) (time frame: During the Study Conduct). 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 7 Dec 2009.