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Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer

NCT00521781 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-03-17

No results posted yet for this study

Summary

The purpose of the clinical trial is to assess the clinical benefit as measured by time to tumor progression of Abraxane plus hormonal therapy when applied to previously untreated patients with unresectable or metastatic adenocarcinoma of the prostate, as well as to assess safety and tolerability of the study drug regimen and to evaluate secondary efficacy endpoints such as overall survival and duration of response.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Abraxane

100 mg/m2 IVPB Day 1, 8, 15, 22, 29,36,43,50 of each cycle for 4 nine-week cycles (Each cycle of Abraxane/hormonal therapy will consist of 8 weeks of Abraxane therapy and 1 week of rest.)

DRUG

Leuprolide

7.5 mg monthly or 22.5 mg quarterly, can begin within 3 months of initiating Abraxane for 2 years

DRUG

Bicalutamide

50 mg p.o. daily starts week 36 of initiating Abraxane.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Robert J Amato, DO · Baylor College of Medicine - Methodist Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-09-30
Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00521781 on ClinicalTrials.gov