CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 658 enrolled
Drug / intervention
ARM 2 +1 moredrug
Likely dose
Panitumumab plus cisplatin and 5-fluorouracil (specific doses not stated in intervention text)AI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma of the head and neck
  • ✓Metastatic disease and/or recurrent disease determined to be incurable by surgery or radiotherapy
  • ✓Age at least 18 years
  • ✓Measurable and non-measurable disease
Key exclusion· 9
  • ✕CNS metastases (history or known presence)
  • ✕Nasopharyngeal carcinoma
  • ✕Prior systemic treatment for metastatic and/or recurrent SCCHN
  • ✕Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy

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

Search/NCT00460265
NCT00460265Phase 3Completed
CompareCT.gov

A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Amgen·interventional·Posted Apr 13, 2007·Updated Mar 7, 2014

In Brief

A Phase 3 clinical trial evaluating ARM 2 and ARM 1 for Recurrent and/or Metastatic Head and Neck Cancer. Completed, enrolled 658 participants.

Detailed Summary

The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent and/or Metastatic Head and Neck Cancer
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2007
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2010
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.2 years ago

Interventions

ARM 2drug

Subjects will receive Cisplatin plus 5FU

ARM 1drug

Subjects will receive Panitumumab plus cisplatin and 5FU