Spots Global Cancer Trial Database for Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

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Trial Identification

Brief Title: Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

Official Title: Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.

Study ID: NCT00905983

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine and Docetaxel

Study Description

Brief Summary: Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.

Detailed Description:

Keywords

Carcinoma, Non-Small-Cell

Elderly patients

Docetaxel

Gemcitabine

Eligibility

Minimum Age: 70 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Virgen de los Lirios, Alcoy, Alicante, Spain

Hospital Clínica de Benidorm, Benidorm, Alicante, Spain

Hospital General de Elda, Elda, Alicante, Spain

Hospital Althaia, Xarxa Asistencial de Manresa, Manresa, Barcelona, Spain

Hospital Provincial de Castellón, Castellón de la Plana, Castellón, Spain

Hospital de Sagunto, Sagunto, Valencia, Spain

Hospital San Juan de Alicante, Alicante, , Spain

Hospital Universitario La Fe, Valencia, , Spain

Instituto Valenciano de Oncología, Valencia, , Spain

Hospital Arnau de Vilanova, Valencia, , Spain

Hospital Universitario Dr. Peset, Valencia, , Spain

Contact Details

Name: Oscar Juan, Doctor

Affiliation: Hospital Arnau de Vilanova de Valencia

Role: STUDY_DIRECTOR

Name: Alfredo Sánchez, Doctor

Affiliation: Hospital Provincial de Castellón