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Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

NCT00124566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2016-01-18

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere based regimens.

Conditions

Interventions

DRUG

Irofulven

Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.45 mg/kg on Days 1 and 8 every 3 weeks.

DRUG

Prednisone

Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.

DRUG

Mitoxantrone

Subjects will receive mitoxantrone in an intravenous (IV) infusion (5 to 15 minutes) at a dose of 12 mg/m\^2 per day, once every 3 weeks.

DRUG

Capecitabine

Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.

DRUG

Irofulven

Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2006-01-31
Completion
2009-12-31

Countries

  • United States
  • Brazil
  • Canada
  • Chile
  • Croatia
  • France
  • Peru
  • Romania
  • Russia

Study Locations

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Entities

Drugs
Diseases

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 NCT00124566 on ClinicalTrials.gov