NCT00151073

Brief Summary

Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone-refractory prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

3.4 years

First QC Date

September 6, 2005

Last Update Submit

January 21, 2015

Conditions

Hormone-Refractory Prostate Cancer

Keywords

ZometaProstate CancerMetastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • The Percent Increase/Decrease in Bone Markers from Baseline to Cycle 2 Day 2 (Day 23) of Treatment

    To assess and compare the effect of zoledronate and docetaxel/estramustine on markers of bone metabolism in patients with hormone-refractory prostate cancer.

    Cycle 2 Day 2 of Treatment (Day 23 of Treatment)

Secondary Outcomes (2)

  • Percentage of Patients that Respond to Treatment

    Post 3 Cycles (63 days)

  • The Number of Toxicities Experienced by Patients

    30 Days Post Treatment

Study Arms (2)

Zoledronate Alone

EXPERIMENTAL

Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.

Drug: Zoledronic acidDrug: EstramustineDrug: Docetaxel

Docetaxel and Estramustine

EXPERIMENTAL

Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.

Drug: Zoledronic acidDrug: EstramustineDrug: Docetaxel

Interventions

Zoledronic acidDRUG
Also known as: Zometa, Zoledronate
Docetaxel and EstramustineZoledronate Alone
EstramustineDRUG
Docetaxel and EstramustineZoledronate Alone
DocetaxelDRUG
Docetaxel and EstramustineZoledronate Alone

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or untreated spinal cord compression.) Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide. Patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy. Prior radiation therapy must have completed more than 4 weeks prior to registration. Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic AcidEstramustineDocetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenes

Study Officials

  • David C. Smith, MD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

April 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2007

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

US(1)