NCT00268710

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®.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

2.1 years

First QC Date

December 21, 2005

Last Update Submit

December 4, 2009

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)

    During the Study Conduct

Secondary Outcomes (6)

  • Analgesics (assessed by Pain Medication Log)

    During the study conduct

  • PSA (PSA response and PSA progression

    During the study conduct

  • Tumor lesion assessment,

    During the study conduct

  • Overall survival

    During the study conduct

  • Progression-free survival

    During the study conduct

  • +1 more secondary outcomes

Interventions

docetaxelDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 :
  • Hematology:
  • Neutrophils ≥ 1.5 x 10\^9/L
  • Hemoglobin \> 10 g/dL (prior transfusion permitted).
  • Platelets ≥ 100 x 10\^9/L
  • 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.
  • Renal function:
  • Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Monique Furlan

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

February 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

December 7, 2009

Record last verified: 2009-12