December 21, 2005 |
July 29, 2008 |
February 2004 |
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire) [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00268710 on ClinicalTrials.gov Archive Site |
- Analgesics (assessed by Pain Medication Log) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- PSA (PSA response and PSA progression [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- Tumor lesion assessment, [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
- Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry
and clinical exams. [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]
|
Same as current |
|
Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC] |
Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC) |
Primary objectives:
- To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting.
Secondary objectives:
- To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC
- To evaluate PSA response (PSA: Prostate Specific Antigen)
- To evaluate symptomatic response
- To evaluate Quality of life
- To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
|
|
Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Prostatic Neoplasms |
Drug: docetaxel |
|
|
|
Completed |
|
March 2006 |
March 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria
- Chemotherapy within the last 4 weeks
- Anti-androgen therapy within the last 4 weeks.
- Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for >2 years.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry.
- Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.
|
Male |
18 Years to 75 Years |
No |
|
|
|
|
NCT00268710 |
Medical Affairs Study Director, sanofi-aventis |
|
Sanofi-Aventis |
Canadian Urologic Oncology Group |
Study Director: |
Monique Furlan |
Sanofi-Aventis |
|
|
Sanofi-Aventis |
July 2008 |