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Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen

NCT00908336 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2009-05-25

No results posted yet for this study

Summary

Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population.

However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy.

This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.

Conditions

Interventions

DRUG

Docetaxel and Erlotinib

Docetaxel (Taxotere®) 75 mg/m2 iv first day of each 21-day cycle. Erlotinib (Tarceva®) 150 mg po days 2-16 of each 21-day cycle. Total: 4 cycles in the absence of disease progression

DRUG

Erlotinib

150 mg/day po daily

Sponsors & Collaborators

  • Hospital Arnau de Vilanova

    lead OTHER

Principal Investigators

  • Oscar Juan, Doctor · Hospital Arnau de Vilanova de Valencia

  • Gaspar Esquerdo, Doctor · Hospital Clínica de Benidorm

  • Alfredo Sánchez, Doctor · Hospital Provincial de Castellón

  • Sonia Maciá, Doctor · Hospital General de Elda

  • Vicente Giner, Doctor · Hospital de Sagunto

  • José Muñoz, Doctor · H. Universitario Dr. Peset

  • Antonio López, Doctor · Hospital San Juan de Alicante

  • Francisco Aparisi, Doctor · Hospital Virgen de los Lirios

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-08-31
Completion
2010-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT00908336 on ClinicalTrials.gov