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CompletedNCT00436839Updated Jul 9, 2012

Taxotere Prostate Cancer New Indication Registration Trial in China

A Phase 3 interventional study of Docetaxel and Mitoxantrone in Prostatic Neoplasms, sponsored by Sanofi. Completed at 1 site in China. Open to male participants. Per ClinicalTrials.gov, last updated 2012-07-09.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
228
Allocation
Randomized
Sex
Male
01

Study summary

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

02

Conditions studied

  • Prostatic Neoplasms

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 228 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
228 participants (actual)

Study arms

  • Experimental
    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

    Drug: Docetaxel · Drug: Prednisone

  • Active comparator
    2

    Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle

    Drug: Mitoxantrone · Drug: Prednisone

Interventions

  • DrugDocetaxel

    75mg/m² intravenously (day 1) every 21 days

  • DrugMitoxantrone

    12mg/m² intravenously every 21 days

  • DrugPrednisone

    10mg orally given daily

06

What researchers measure

Primary outcomes

  1. Efficacy: Overall survival

    Time frame: From beginning to end of the study

  2. Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours

    Time frame: From beginning to end of study

  3. Prostatic Specific Antigen response

    Time frame: From the beginning to the end of study

  4. Pain response (McGill-Melzack Scale)

    Time frame: From beginning to end of study

  5. Time to progression

    Time frame: From beginning to end of study

  6. Adverse event

    Time frame: From beginning to end of study

  7. Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used

    Time frame: From beginning to end of study

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Shanghai, China
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00436839
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Feb 19, 2007
Start date
Jan 2007
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jul 9, 2012

Study contacts

Jing Fu
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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