Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Carcinoma, Non-Small-Cell, Elderly patients, Docetaxel, Gemcitabine
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.
Interventions
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
Hospital Arnau de Vilanova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of advanced NSCLC. * Stage III with pleural effusion and stage IV. * Patients are 70 years old. * Patients with 1 \> ECOG PS =1. * Patients must have at least one measurable lesion, no previously irradiated. * Life expectancy of at least 12 weeks. * Adequate organ function according to the following criteria: * Bone marrow: ANC \>= 2.0x10(9)cells/L; Platelet count \>= 100x10(9)cells/L; Leukocyte count \>= 4000x10(6)/L; Hemoglobin \>= 10 g/dL. * Liver function: Bilirubin \<= 1.5 X ULN; Alkaline phosphatase \<= 5 x ULN;AST and ALT \<= 1.5 x ULN. * Renal function: serum creatinine \<= 2mg/dL.
Exclusion criteria
* Prior systemic chemotherapy for advanced disease. * Patients with symptomatic brain metastases. * No measurable bone metastases or malignant pleural effusion as only measurable lesion. * History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years. * History of hypersensitivity reaction to study drugs. * Concurrent treatment with other experimental drugs. * Current peripheral neuropathy NCI grade 2. * Participation in clinical trials within 30 days of study entry. * Major surgery, open biopsy or traumatic lesion 28 days before to study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate = sum of complete and partial tumour responses divided by the number of included patients | 2 & 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | time from study entry to death from any cause |
| Toxicity | biweekly |
| Duration of response | time from first response (CR or PR) to tumor progression |
| Time to progression | time from study entry to observed tumor progression or death due to progression disease |
| Measurement of quality of life | 28 days |
Countries
Spain
Outcome results
None listed