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CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer

NCT00330746 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-05-18

No results posted yet for this study

Summary

The purpose of this study is to select the more promising method of combining cetuximab with gemcitabine for treating patients with advanced non small-cell lung cancer, who are not candidates for platinum based therapy.

Conditions

Interventions

DRUG

cetuximab

400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression

DRUG

gemcitabine

1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles

DRUG

gemcitabine

1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles

DRUG

cetuximab

400 mg/m2 first dose followed by 250 mg/m2 weekly

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Cesare Gridelli, M.D. · S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology

  • Fortunato Ciardiello, M.D., Ph.D · Second Univesity of Naples, Italy; Chair Medical Oncology

  • Francesco Perrone, M.D., Ph.D · National Cancer Institute Naples, Italy; Director Clinical Trials Unit

  • Ciro Gallo, M.D., Ph.D · Second University of Naples, Italy; Chair of Medical Statistics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-01-31
Completion
2008-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT00330746 on ClinicalTrials.gov