Taxotere Prostate Cancer New Indication Registration Trial in China

Phase 3

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Docetaxel; Drug: Mitoxantrone; Drug: Prednisone

• Registration Number: NCT00436839
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 228

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
1	Prednisone	Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
2	Mitoxantrone	Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle
2	Prednisone	Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle

Primary Outcome Measures

Name	Time	Method
Efficacy: Overall survival	From beginning to end of the study
Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours	From beginning to end of study
Prostatic Specific Antigen response	From the beginning to the end of study
Pain response (McGill-Melzack Scale)	From beginning to end of study
Time to progression	From beginning to end of study
Adverse event	From beginning to end of study
Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used	From beginning to end of study

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Shanghai, China