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Taxotere Prostate Cancer New Indication Registration Trial in China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00436839
First received: February 16, 2007
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
Drug: Docetaxel
Drug: Mitoxantrone
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Enrollment: 228
Study Start Date: January 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436839

Locations
China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jing Fu Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00436839     History of Changes
Other Study ID Numbers: DOCET_L_01833
Study First Received: February 16, 2007
Last Updated: July 5, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Mitoxantrone
Prednisone
Analgesics
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Central Nervous System Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014