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Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)

NCT00661492 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2016-12-09

Study results available
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Summary

To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment date to the date the patient is first recorded as having disease progression, even in patients who discontinue study treatment early due to toxicity.

Conditions

  • Androgen-independent Prostate Cancer

Interventions

DRUG

cetuximab

Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter

DRUG

Mitoxantrone

Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all patients who enter study on LHRH agonists

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Oregon Health and Science University

    collaborator OTHER

  • US Oncology Research

    lead INDUSTRY

Principal Investigators

  • Mark T. Fleming, MD · Virginia Oncology Associates/US Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-03-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00661492 on ClinicalTrials.gov