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Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer

NCT01264328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-16

No results posted yet for this study

Summary

The clinical hypothesis of this study is that the first-line treatment with the combination of panitumumab and paclitaxel will provide benefit for patients with metastatic or current Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions

Interventions

DRUG

Panitumumab + paclitaxel

Paclitaxel 80 mg/m2 may be infused, intravenously, over one hour every week. Panitumumab will be administered every 2 weeks at a dose of 6 mg/kg, using a non pyrogenic low protein binding filter with a 0.20-0.22-μm pore size intravenously over 1 hour ± 15 minutes. Panitumumab will be administered prior to paclitaxel.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Trial Form Support S.L.

    collaborator OTHER

  • Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

    lead OTHER

Principal Investigators

  • Juan Jesús Cruz Hernández, Professor · University of Salamanca

  • Javier Martínez Trufero, MD · Hospital Miguel Servet de Zaragoza

  • Juan José Grau, MD · Hospital Clínic i Provincial de Barcelona

  • Joaquina Martínez, MD · Hospital Virgen de las Nieves (Granada)

  • Antonio López Pousa, MD · Hospital de la Santa Creu i Sant Pau de Barcelona

  • Alfonso Berrocal, MD · Hospital General Universitario de Valencia

  • Ricardo Hitt, MD · Hospital 12 de Octubre de Madrid

  • Ricardo Mesia, MD · Institut Català d'Oncología. Hospital Duran i Reynals de Barcelona

  • Elvira del Barco Morillo, MD · University of Salamanca

  • Carlos García, MD · Hospital General Yagüe de Burgos

  • Alicia Hurtado, MD · Fundación Hospitalaria de Alcorcón de Madrid

  • Miguel Pastor, MD · Hospital La Fe de Valencia

  • Ruth Vera García, MD · Hospital de Navarra

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-09
Primary Completion
2011-10-31
Completion
2014-09-29

Countries

  • Spain

Study Locations

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Entities

Diseases
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 NCT01264328 on ClinicalTrials.gov