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PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

NCT00454779 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2018-10-17

Study results available
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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.

Conditions

  • Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Cisplatin

chemotherapy arm

DRUG

Panitumumab

experimental arm

DRUG

Docetaxel

chemotherapy arm

DRUG

Cisplatin

experimental arm

DRUG

Docetaxel

experimental arm

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2012-06-11
Completion
2014-01-01

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • France
  • Lithuania
  • Puerto Rico
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454779 on ClinicalTrials.gov