Clinical trial NCT00436839: Taxotere Prostate Cancer New Indication Registration Trial in China
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 228
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.


Eligibility criteria: Inclusion Criteria:

* 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)
* 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 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:

  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.

Primary outcomes:
measure: Efficacy: Overall survival
timeFrame: From beginning to end of the study
measure: Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours
timeFrame: From beginning to end of study
measure: Prostatic Specific Antigen response
timeFrame: From the beginning to the end of study
measure: Pain response (McGill-Melzack Scale)
timeFrame: From beginning to end of study
measure: Time to progression
timeFrame: From beginning to end of study
measure: Adverse event
timeFrame: From beginning to end of study
measure: Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used
timeFrame: From beginning to end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jing Fu
role: STUDY_DIRECTOR
References:
citation: 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.