CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Erlotinibdrug
Likely dose
Erlotinib 150 mg orally once daily for 12 monthsAI-extracted
Key inclusion· 6
  • ✓Pathologically confirmed recurrent or second primary squamous cell carcinoma of head and neck (oral cavity, oropharynx, hypopharynx, larynx, or recurrent neck metastasis with unknown primary)
  • ✓Prior radiation therapy for head and neck cancer
  • ✓Disease must be surgically resectable or candidate for curative reirradiation
  • ✓Zubrod Performance Status 0-2
Key exclusion· 4
  • ✕Prior invasive cancers other than head and neck cancer unless disease-free for minimum 3 years (prior non-melanomatous skin cancer and carcinoma in situ are allowed)
  • ✕Pregnant or lactating patients
  • ✕Psychological condition that renders patient unable to understand informed consent
  • ✕Any situation or condition that will interfere with adherence to study activities

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

Search/NCT00570232
NCT00570232Phase 2Completed
CompareCT.gov

Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer

University of Alabama at Birmingham·interventional·Posted Dec 10, 2007·Updated May 21, 2015

In Brief

A Phase 2 clinical trial evaluating Erlotinib for Head and Neck Cancer. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsGenentech, Inc., OSI Pharmaceuticals

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2007
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 18.6 years ago

Interventions

Erlotinibdrug

150 mg per day by mouth for 12 months