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Taxotere Prostate Cancer New Indication Registration Trial in China

Primary Purpose

Prostatic Neoplasms

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Docetaxel

Mitoxantrone

Prednisone

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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:
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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Efficacy: Overall survival

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

Prostatic Specific Antigen response

Pain response (McGill-Melzack Scale)

Time to progression

Adverse event

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00436839

First Posted

February 16, 2007

Last Updated

July 5, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00436839

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mitoxantrone

Intervention Description

12mg/m² intravenously every 21 days

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

10mg orally given daily

Primary Outcome Measure Information:

Title

Efficacy: Overall survival

Time Frame

From beginning to end of the study

Title

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

Time Frame

From beginning to end of study

Title

Prostatic Specific Antigen response

Time Frame

From the beginning to the end of study

Title

Pain response (McGill-Melzack Scale)

Time Frame

From beginning to end of study

Title

Time to progression

Time Frame

From beginning to end of study

Title

Adverse event

Time Frame

From beginning to end of study

Title

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

Time Frame

From beginning to end of study

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Fu

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Shanghai

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25625938

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.

Results Reference

derived

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Taxotere Prostate Cancer New Indication Registration Trial in China

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