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Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT00678964 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2008-05-16

No results posted yet for this study

Summary

60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients.

Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer.

Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.

Conditions

Interventions

DRUG

Erlotinib

Erlotinib 150 mg, p.o., once daily

DRUG

Vinorelbine and Carboplatin

Vinorelbine 25 mg/m2, i.v., day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v., day 1 of every cycle

Sponsors & Collaborators

  • LungenClinic Grosshansdorf

    lead OTHER

Principal Investigators

  • Martin Reck, Dr. · LungenClinic Grosshansdorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-11-30

Countries

  • Germany

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 NCT00678964 on ClinicalTrials.gov