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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital San Juan de Alicante
Alicante, 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
Castellon, Castellón, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, Spain
...and 1 more locations
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Time frame: 2 & 4 months
Overall survival
Time frame: time from study entry to death from any cause
Toxicity
Time frame: biweekly
Duration of response
Time frame: time from first response (CR or PR) to tumor progression
Time to progression
Time frame: time from study entry to observed tumor progression or death due to progression disease
Measurement of quality of life
Time frame: 28 days
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