Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC] - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 21, 2005

Last Updated Date

July 29, 2008

Start Date ^†

February 2004

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00268710 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]

Official Title ^†

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)

Brief Summary

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®.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Prostatic Neoplasms

Intervention ^†

Drug: docetaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

March 2006

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Histologically/cytologically proven prostate adenocarcinoma
Progression or non response with previous chemotherapy regimen (excluding Taxotere®)
Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine
Castration levels of testosterone (<50 ng/dL )
ECOG performance status 0-2
Laboratory requirements :
1. Hematology:
  - Neutrophils ≥ 1.5 x 10^9/L
  - Hemoglobin > 10 g/dL (prior transfusion permitted).
  - Platelets ≥ 100 x 10^9/L
2. Hepatic function:
  - Total bilirubin < the upper-normal limit of the institution.
  - ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the institution.
3. Renal function:
  - Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)
No severe or uncontrolled disease

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.

Gender

Male

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268710

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Secondary IDs ^††

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Canadian Urologic Oncology Group

Investigators ^†

Study Director:

Monique Furlan

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.