CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Erlotinib +1 moredrug
Likely dose
Erlotinib 150 mgfrom 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/NCT00380029
NCT00380029Phase 2Completed
CompareCT.gov

A Phase II Study of Erlotinib (Tarceva®) in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Sep 25, 2006·Updated Jul 19, 2017

In Brief

A Phase 2 clinical trial evaluating Erlotinib and Radical Cystectomy for Bladder Cancer. Completed, enrolled 27 participants across 1 site.

Detailed Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well erlotinib works when given before and after surgery in treating patients with muscle-invasive bladder cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsOSI Pharmaceuticals, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 25, 2006
Enrollment StartMay 1, 2006
Primary CompletionAug 1, 2010
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.8 years ago

Interventions

Erlotinibdrug

Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression

Radical Cystectomyprocedure

Will occur 4 weeks prior to dosing with erlotinib