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Brief Title: Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Official Title: Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
Study ID: NCT00906061
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Virgen de los Lirios, Alcoy, Alicante, Spain
Hospital ClĂnica de Benidorm, Benidorm, Alicante, Spain
Hospital General de Elda, Elda, Alicante, Spain
Hospital Althaia, Xarxa Asistencial de Manresa, Manresa, Barcelona, Spain
Hospital Provincial de CastellĂłn, CastellĂłn de la Plana, CastellĂłn, Spain
Hospital de Sagunto, Sagunto, Valencia, Spain
Hospital Universitario de Alicante, Alicante, , Spain
Hospital San Juan de Alicante, Alicante, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Instituto Valenciano de OncologĂa, Valencia, , Spain
Hospital Arnau de Vilanova, Valencia, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Name: Oscar Juan, Doctor
Affiliation: Hospital Arnau de Vilanova de Valencia
Role: STUDY_DIRECTOR
Name: Alfredo Sanchez, Doctor
Affiliation: Hospital Provincial de CastellĂłn
Role: PRINCIPAL_INVESTIGATOR
Name: José Muñoz, Doctor
Affiliation: H. Universitario Dr. Peset
Role: PRINCIPAL_INVESTIGATOR
Name: Sonia MaciĂĄ, Doctor
Affiliation: Hospital General de Elda
Role: PRINCIPAL_INVESTIGATOR
Name: Vicente Giner, Doctor
Affiliation: Hospital de Sagunto
Role: PRINCIPAL_INVESTIGATOR
Name: José Gomez, Doctor
Affiliation: Hospital Universitario La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: Gaspar Esquerdo, Doctor
Affiliation: Hospital ClĂnica de Benidorm
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio LĂłpez, Doctor
Affiliation: Hospital San Juan de Alicante
Role: PRINCIPAL_INVESTIGATOR
Name: Francisco Aparisi, Doctor
Affiliation: Hospital Virgen de los Lirios
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel A. Muñoz, Doctor
Affiliation: Instituto Valenciano de OncologĂa
Role: PRINCIPAL_INVESTIGATOR
Name: Juan L. MartĂ, Doctor
Affiliation: Hospital Universitario de Alicante
Role: PRINCIPAL_INVESTIGATOR
Name: Silvia Catot, Doctor
Affiliation: Hospital Althaia, Xarxa Asistencial de Manresa
Role: PRINCIPAL_INVESTIGATOR