NCT00193193

Brief Summary

In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Aug 2000

Typical duration for phase_2 prostate-cancer

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

August 1, 2000

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

August 4, 2010

Status Verified

July 1, 2010

Enrollment Period

3.3 years

First QC Date

September 12, 2005

Last Update Submit

August 3, 2010

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

Secondary Outcomes (2)

  • Toxicity

  • Overall survival

Interventions

PaclitaxelDRUG
EstramustineDRUG
CarboplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Adenocarcinoma of the prostate not curable with local treatment
  • Disease progression while receiving hormonal therapy
  • Measurable or evaluable disease
  • Previous treatment with a maximum of one prior chemotherapy regimen
  • ECOG performance status 0, 1, or 2.
  • Adequate bone marrow, liver and kidney function
  • Able to comprehend the nature of this study and give written informed consent

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Age \< 18 years
  • History of treatment for an invasive malignancy within five years
  • Significant heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PaclitaxelEstramustineCarboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsCoordination Complexes

Study Officials

  • John D. Hainsworth, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

August 1, 2000

Primary Completion

December 1, 2003

Study Completion

February 1, 2007

Last Updated

August 4, 2010

Record last verified: 2010-07