NCT00099086

Brief Summary

This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1 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

First Submitted

Initial submission to the registry

December 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 16, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2011

Completed
12.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

December 8, 2004

Last Update Submit

January 29, 2024

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy

    To determine the MTD of Taxotere with radiation therapy and hormonal therapy in patients with high risk locally advanced adenocarcinoma of the prostate. The dose limiting toxicity (CLT) period for determining the MTD is 57 days.

    57 days

Study Arms (1)

Experimental Arm

EXPERIMENTAL
Drug: BicalutamideDrug: docetaxelDrug: GnRh analogRadiation: radiotherapy

Interventions

BicalutamideDRUG

Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

Also known as: Casodex
Experimental Arm
docetaxelDRUG

Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2

Also known as: Taxotere
Experimental Arm
GnRh analogDRUG

A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months) Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

Also known as: Zoladex, goserelin acetate, leuprolide acetate, Lupron
Experimental Arm
radiotherapyRADIATION

External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.

Experimental Arm

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis
  • No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
  • Performance status 0-2
  • Must meet criteria for acceptable lab values as outlined in the protocol.
  • Peripheral neuropathy must be greater than or equal to 1
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

You may not qualify if:

  • \. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamideDocetaxelGonadotropin-Releasing HormoneGoserelinLeuprolideRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsTherapeutics

Study Officials

  • David Marshall, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2004

First Posted

December 9, 2004

Study Start

January 16, 2007

Primary Completion

January 20, 2011

Study Completion

December 13, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01