Taxotere Prostate Cancer New Indication Registration Trial in China

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436839
• Other study ID #: DOCET_L_01833
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2007
• Last updated: July 5, 2012
• Start date: January 2007
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel
75mg/m² intravenously (day 1) every 21 days
• Mitoxantrone
12mg/m² intravenously every 21 days
• Prednisone
10mg orally given daily

Locations

Country	Name	City	State
China	Sanofi-Aventis Administrative Office	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Overall survival		From beginning to end of the study	No
Primary	Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours		From beginning to end of study	No
Primary	Prostatic Specific Antigen response		From the beginning to the end of study	No
Primary	Pain response (McGill-Melzack Scale)		From beginning to end of study	No
Primary	Time to progression		From beginning to end of study	No
Primary	Adverse event		From beginning to end of study	Yes
Primary	Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used		From beginning to end of study	No