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Paclitaxel vs Paclitaxel + Cetuximab in Recurrent - Metastatic Head & Neck Carcinoma After Failure of a 1º Chemotherapy

NCT03887442 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-01-07

Study results available
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Summary

Treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) after progression to first line EXTREME-type treatment in patients undergoing maintenance treatment with cetuximab.

Conditions

Interventions

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 may be infused, intravenously, every week.

DRUG

Cetuximab + Paclitaxel

Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Pivotal S.L.

    collaborator INDUSTRY

  • Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

    lead OTHER

Principal Investigators

  • Ricard Mesía, MD · Institut Català d´Oncologia-Duran i Reynals

  • Juan J. Grau, MD · Hospital Clinic of Barcelona

  • Elvira del Barco, MD · University of Salamanca

  • Ruth Vera, MD · Complejo Hospitalario de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-16
Primary Completion
2012-10-02
Completion
2012-10-02

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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 NCT03887442 on ClinicalTrials.gov