Taxotere Prostate Cancer New Indication Registration Trial in China

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00436839

Collaborator

(none)

228

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: Docetaxel Drug: Mitoxantrone Drug: Prednisone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 75mg/m² intravenously (day 1) every 21 days Drug: Prednisone 10mg orally given daily
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 12mg/m² intravenously every 21 days Drug: Prednisone 10mg orally given daily

Arm

Intervention/Treatment

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

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

Drug: Prednisone

10mg orally given daily

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

12mg/m² intravenously every 21 days

Drug: Prednisone

10mg orally given daily

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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:

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

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.

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:

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.
Active uncontrolled infection
Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Shanghai		China

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Jing Fu, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT00436839

Other Study ID Numbers:

DOCET_L_01833

First Posted:

Feb 19, 2007

Last Update Posted:

Jul 9, 2012

Last Verified:

Jul 1, 2012

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2012