Prostatic NeoplasmsPhase 3NCT00436839
Taxotere Prostate Cancer New Indication Registration Trial in China
A Phase 3 study testing Docetaxel, Mitoxantrone and Prednisone in people with Prostatic Neoplasms, run by Sanofi at 1 site in China.
Trial summary
To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Docetaxel, Mitoxantrone and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Jun 2012
- Phase
- Phase 3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically proven prostate adenocarcinoma
- Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone < 50 ng/dl (ie 1.735 nmol/l)
- Documented progressive disease
- Patients should have achieved stable analgesia for 7 days
- Karnofsky Performance Status ≥ 70
- No prior treatment with cytotoxic agent (except estramustine)
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- Normal cardiac function must be confirmed by Left ventricular ejection fraction
- Adequate organ function:
- Hematology:
- Neutrophils > 1.5 x 10^9/L
- Hemoglobin > 10 g/dl. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed
- Platelets > 100 x 10^9/L
- Hepatic function:
- Total bilirubin < the upper-normal limit of the institution.
- Alanine aminotransferase and Aspartate transaminase < 1.5 times the upper-normal limit of the institution.
- Renal function:
- Creatinine < 1.5 times the upper normal limit (ie National Cancer Institution grade < 1)
- No brain or leptomeningeal metastases
Who cannot join
- Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed)
- prior cytotoxic chemotherapy, except monotherapy with estramustine
- prior isotope therapy
- history of another cancer within the preceding five year
- symptomatic peripheral neuropathy grade ≥ 2
- other serious illness or medical condition:
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- Congestive heart failure even if controlled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias.
- Active uncontrolled infection
- Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids.
- Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis)
- treatment with any other anti-cancer therapy
- treatment with bisphosphonates
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer
To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.
- Conditions
- Prostatic Neoplasms
- Being tested
- Docetaxel, Mitoxantrone, Prednisone
- 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
75mg/m² intravenously (day 1) every 21 days
MitoxantroneDrug
12mg/m² intravenously every 21 days
PrednisoneDrug
10mg orally given daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle Receives: Drug: Docetaxel; Drug: Prednisone |
| 2 | Active comparator | Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle Receives: Drug: Mitoxantrone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Overall survival
Measured: From beginning to end of the study
Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours
Measured: From beginning to end of study
Prostatic Specific Antigen response
Measured: From the beginning to the end of study
Pain response (McGill-Melzack Scale)
Measured: From beginning to end of study
Time to progression
Measured: From beginning to end of study
Adverse event
Measured: From beginning to end of study
Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used
Measured: From beginning to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2012
- Study completionJun 2012
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Fu, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436839
- Sponsor's protocol ID
- DOCET_L_01833
- Status last verified
- Jul 2012
- First submitted
- 16 Feb 2007
- Last updated
- 9 Jul 2012
- Results posted
- No
Publications
Zhou T, Zeng SX, Ye DW, Wei Q, Zhang X, Huang YR, Ye ZQ, Yang Y, Zhang W, Tian Y, Zhou FJ, Jie J, Chen SP, Sun Y, Xie LP, Yao X, Na YQ, Sun YH. A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer. PLoS One. 2015 Jan 27;10(1):e0117002. doi: 10.1371/journal.pone.0117002. eCollection 2015.
PubMed 25625938
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00436839
- Acronym / sponsor ID
- DOCET_L_01833
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Feb 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.
To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel, Drug: PrednisoneDocetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle |
| 2 | Active comparator | Drug: Mitoxantrone, Drug: PrednisoneMitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically proven prostate adenocarcinoma
- Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone < 50 ng/dl (ie 1.735 nmol/l)
- Documented progressive disease
- Patients should have achieved stable analgesia for 7 days
- Karnofsky Performance Status ≥ 70
Key exclusion criteria (13 listed)
- Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed)
- prior cytotoxic chemotherapy, except monotherapy with estramustine
- prior isotope therapy
- history of another cancer within the preceding five year
- symptomatic peripheral neuropathy grade ≥ 2
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 |
|---|---|---|
| Docetaxel75mg/m² intravenously (day 1) every 21 days | Drug | 1 |
| Mitoxantrone12mg/m² intravenously every 21 days | Drug | 2 |
| Prednisone10mg orally given daily | Drug | 1, 2 |
Primary outcome
Efficacy: Overall survival
Time frame: From beginning to end of the study
Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours
Time frame: From beginning to end of study
Prostatic Specific Antigen response
Time frame: From the beginning to the end of study
Pain response (McGill-Melzack Scale)
Time frame: From beginning to end of study
Time to progression
Time frame: From beginning to end of study
Adverse event
Time frame: From beginning to end of study
Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used
Time frame: From beginning to end of 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 9 Jul 2012.
- Derived from this study: PubMed 25625938Zhou T, Zeng SX, Ye DW, Wei Q, Zhang X, Huang YR, Ye ZQ, Yang Y, Zhang W, Tian Y, Zhou FJ, Jie J, Chen SP, Sun Y, Xie LP, Yao X, Na YQ, Sun YH. A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer. PLoS One. 2015 Jan 27;10(1):e0117002. doi: 10.1371/journal.pone.0117002. eCollection 2015.
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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.
Jing Fu study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, Mitoxantrone and Prednisone in people with Prostatic Neoplasms, run by Sanofi at 1 site in China.
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 18 inclusion and 13 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 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy: Overall survival (time frame: From beginning to end of the study). The study lists 7 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 NCT00436839, 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 9 Jul 2012.