NCT00005096

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Dec 1999

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

3 active sites

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

December 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

March 4, 2004

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

April 6, 2000

Last Update Submit

July 12, 2017

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage II prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Complete Response Rate

    Wilcoxon Signed Rank Test

    2 Months, 6 Months

Secondary Outcomes (1)

  • Percentage of Participants with mild to moderate toxicity

    6 months

Study Arms (1)

Docetaxel

EXPERIMENTAL

Docetaxel given via iv at determined dose once a week for 4 weeks

Drug: docetaxel

Interventions

docetaxelDRUG
Also known as: Taxotere
Docetaxel

Eligibility Criteria

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

You may not qualify if:

  • No prior hormones, radiation or chemotherapy for prostate cancer
  • Evidence of serious active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

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

  • Mary-Ellen Taplin, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taplin, Mary-Ellen

Study Record Dates

First Submitted

April 6, 2000

First Posted

March 4, 2004

Study Start

December 1, 1999

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)