Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2

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.

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced NSCLC.

• Stage III with pleural effusion and stage IV.

• Patients with ECOG PS 2.

• 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; 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.
• Prior radiotherapy for NSCLC.
• 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 study drugs.
• Pregnant or lactating women (women of childbearing potential must use adequate contraception).
• 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.