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

Hellenic Oncology Research Group

Status and phase

Completed

Phase 3

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Gemcitabine

Drug: Vinorelbine

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00441740

CT/04.04

Details and patient eligibility

About

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.

Full description

Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.

Enrollment

419 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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