Taxotere Prostate Cancer New Indication Registration Trial in China
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00436839
First received: February 16, 2007
Last updated: July 5, 2012
Last verified: July 2012
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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:
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 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:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Docetaxel Mitoxantrone Prednisone Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013