CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Erlotinibdrug
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/NCT00369512
NCT00369512Phase 2Completed

A Phase II Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas

University of Alabama at Birmingham·interventional·Posted Aug 29, 2006·Updated May 30, 2017

In Brief

A Phase 2 clinical trial evaluating Erlotinib for Cancer. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical resection. Following planned surgical resection, the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2006
Enrollment StartAug 1, 2006
Primary CompletionJan 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 19.8 years ago

Interventions

Erlotinibdrug

Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).