drugset / Trial / NCT00906061

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

NCT00906061 ↗

Phase 2 Unknown 76 enrolled Hospital Arnau de Vilanova
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-10
Primary completion
2009-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Gemcitabine Small molecule 2000 mg/m2 Intravenous