CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Cetuximab +3 moredrug
Likely dose
Cetuximab 400 mg/m2from 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/NCT01218048
NCT01218048Phase 2Completed
CompareCT.gov

Phase II Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Followed by Adjuvant Therapy With Concurrent Chemoradiotherapy or Radiotherapy With or Without Cetuximab for Locally Advanced Head and Neck Squamous Cell Carcinoma

Robert Ferris·interventional·Posted Oct 8, 2010·Updated Aug 16, 2018

In Brief

A Phase 2 clinical trial evaluating Cetuximab, Surgery, and 2 other interventions for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 40 participants across 1 site.

Detailed Summary

There are currently no useful tests to identify patients who will respond to cetuximab therapy, notably because EGFR levels do not correlate with the clinical responses observed. Thus, the investigators are investigating the role of cellular immunity and immune escape mechanisms to explain the differential clinical response to cetuximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2010
Enrollment StartFeb 1, 2011
Primary CompletionNov 4, 2015
Study CompletionFeb 14, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.7 years ago

Interventions

Cetuximabdrug

Pre-Surgery: IV, 400 mg/m2 day 1 then 250 mg/m2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT

Surgeryprocedure

Surgery for tumor

Post-surgical radiationradiation

Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery

Cisplatin or carboplatindrug

Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy