Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Docetaxel; Gemcitabine; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC

• No previous therapy for advanced/metastatic NSCLC is allowed

• Age > 18 years

• Bidimensionally measurable disease

• Performance status (WHO) 0-2

• Adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function

• Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields

• Life expectancy of more than 3 months

• Patient able to take oral medication

• At least 4 weeks since prior radiotherapy

• Written informed consent

Exclusion Criteria:

• Active infection

• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

• Malnutrition (loss of ≥ 20% of the original body weight)

• Performance status: 3-4

• Sensor or motor neuropathy > grade I

• Second primary malignancy, except for non-melanoma skin cancer

• Psychiatric illness or social situation that would preclude study compliance

• Pregnant or lactating women

• Known, symptomatic central nervous system metastases