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

• Overall survival [ Time Frame: time from study entry to death from any cause ] [ Designated as safety issue: No ]
• Toxicity [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
• Duration of response [ Time Frame: time from first response (CR or PR) to tumor progression ] [ Designated as safety issue: No ]
• Time to progression [ Time Frame: time from study entry to observed tumor progression or death due to progression disease ] [ Designated as safety issue: No ]
• Measurement of quality of life [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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.

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.