Taxotere Prostate Cancer New Indication Registration Trial in China
NCT ID: NCT00436839
Last Updated: 2012-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2007-01-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
Docetaxel
75mg/m² intravenously (day 1) every 21 days
Prednisone
10mg orally given daily
2
Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
Mitoxantrone
12mg/m² intravenously every 21 days
Prednisone
10mg orally given daily
Interventions
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Docetaxel
75mg/m² intravenously (day 1) every 21 days
Mitoxantrone
12mg/m² intravenously every 21 days
Prednisone
10mg orally given daily
Eligibility Criteria
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Inclusion Criteria
* 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)
* Normal cardiac function must be confirmed by Left ventricular ejection fraction
* Adequate organ function:
1. 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
2. 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.
3. Renal function:
* Creatinine \< 1.5 times the upper normal limit (ie National Cancer Institution grade \< 1)
* No brain or leptomeningeal metastases
Exclusion Criteria
* 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:
1. 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.
2. Active uncontrolled infection
3. Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids.
4. 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.
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Jing Fu
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Shanghai, , China
Countries
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References
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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.
Other Identifiers
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DOCET_L_01833
Identifier Type: -
Identifier Source: org_study_id