Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

Summary

There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.

This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.

In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.

The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Gemcitabine and Docetaxel

Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6

Sponsors & Collaborators

• Hospital Arnau de Vilanova

  lead OTHER

Principal Investigators

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

• Alfredo Sanchez, Doctor · Hospital Provincial de Castellón

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

• Sonia Maciá, Doctor · Hospital General de Elda

• Vicente Giner, Doctor · Hospital de Sagunto

• José Gomez, Doctor · Hospital Universitario La Fe

• Gaspar Esquerdo, Doctor · Hospital Clínica de Benidorm

• Antonio López, Doctor · Hospital San Juan de Alicante

• Francisco Aparisi, Doctor · Hospital Virgen de los Lirios

• Miguel A. Muñoz, Doctor · Instituto Valenciano de Oncología

• Juan L. Martí, Doctor · Hospital Universitario de Alicante

• Silvia Catot, Doctor · Hospital Althaia, Xarxa Asistencial de Manresa

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2009-10-31

Completion

2011-10-31

Countries

• Spain

Study Locations