[A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]

J Tredaniel; F Mornex; I Barillot; O Diaz; C Hennequin; C Le Pechoux; A Lavole; P Giraud; P-J Souquet; L Teixeira; F Vaylet; G Zalcman; L Baudrin; F Morin; B Milleron

doi:10.1016/j.rmr.2010.06.027

[A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]

Rev Mal Respir. 2011 Jan;28(1):51-7. doi: 10.1016/j.rmr.2010.06.027. Epub 2011 Jan 11.

[Article in French]

Authors

J Tredaniel¹, F Mornex, I Barillot, O Diaz, C Hennequin, C Le Pechoux, A Lavole, P Giraud, P-J Souquet, L Teixeira, F Vaylet, G Zalcman, L Baudrin, F Morin, B Milleron

Affiliation

¹ Unité de Cancérologie Thoracique, Hôpital Saint-Joseph, 185 Rue Raymond-Losserand, 75674 Paris cedex 14, France. [email protected]

PMID: 21277474
DOI: 10.1016/j.rmr.2010.06.027

Abstract

Background: Cisplatin-based chemotherapy and concurrent radiotherapy are the standard treatments for locally advanced unresectable NSCLC. New therapeutic combinations using molecular targeted drugs are needed.

Methods: Eligible patients with previously untreated stage III non squamous, NSCLC will receive thoracic radiation (66 Gy) along with cisplatin (75 mg/m(2)) and pemetrexed (500 mg/m(2)) on day 1 administered intravenously every 21 days for four cycles; weekly cetuximab will be added from the first week of therapy. The primary objective of this phase II study (IFCT 0803) is to assess the disease control rate at the 16th week, one month after the completion of the treatment. Based on a two-stage Simon approach, a total of 106 patients are required with an interim analysis of the first 34 planned.

Expected results: This trial will provide information on the feasibility, efficacy and tolerability of this new therapeutic combination. Should the primary objective be achieved, a phase III randomised study testing the position of cetuximab could be considered.

Publication types

Clinical Trial, Phase II
English Abstract
Multicenter Study

MeSH terms

Aged
Antibodies, Monoclonal / administration & dosage
Antibodies, Monoclonal / adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Carcinoma, Non-Small-Cell Lung / drug therapy*
Carcinoma, Non-Small-Cell Lung / mortality
Carcinoma, Non-Small-Cell Lung / pathology
Carcinoma, Non-Small-Cell Lung / radiotherapy*
Cetuximab
Cisplatin / administration & dosage
Cisplatin / adverse effects
Combined Modality Therapy
Drug Administration Schedule
Feasibility Studies
Female
Follow-Up Studies
Glutamates / administration & dosage
Glutamates / adverse effects
Guanine / administration & dosage
Guanine / adverse effects
Guanine / analogs & derivatives
Humans
Infusions, Intravenous
Kaplan-Meier Estimate
Lung Neoplasms / drug therapy*
Lung Neoplasms / mortality
Lung Neoplasms / pathology
Lung Neoplasms / radiotherapy*
Male
Middle Aged
Neoplasm Staging
Pemetrexed
Radiotherapy Dosage

Substances

Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Glutamates
Pemetrexed
Guanine
Cetuximab
Cisplatin