CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
Cisplatin +4 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/NCT00454779
NCT00454779Phase 2Completed

A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…

Amgen·interventional·Posted Apr 2, 2007·Updated Oct 17, 2018

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Panitumumab, and 1 other intervention for Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 113 participants across 114 sites in 9 countries.

Detailed Summary

This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Czechia, France, Lithuania, Puerto Rico, Slovakia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2, 2007
Enrollment StartJan 1, 2007
Primary CompletionJun 11, 2012
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 19.3 years ago

Interventions

Cisplatindrug

chemotherapy arm

Panitumumabdrug

experimental arm

Docetaxeldrug

chemotherapy arm

Cisplatindrug

experimental arm

Docetaxeldrug

experimental arm