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

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Arnau de Vilanova
• Treatments: Docetaxel; Gemcitabine

Criteria

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.