CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 115 enrolled
Drug / intervention
cetuximab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00661492
NCT00661492Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-based Chemotherapy

US Oncology Research·interventional·Posted Apr 18, 2008·Updated Dec 9, 2016

In Brief

A Phase 2 clinical trial evaluating cetuximab and Mitoxantrone for Androgen-independent Prostate Cancer. Completed, enrolled 115 participants across 55 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAndrogen-independent Prostate Cancer
CountriesUnited States
CollaboratorsEli Lilly and Company, Oregon Health and Science University

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.2 years ago

Interventions

cetuximabdrug

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

Mitoxantronedrug

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