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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Vinorelbine
* Drug: Gemcitabine
* Drug: Docetaxel
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>VG | Drug: Vinorelbine<br>* Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles<br>* Other names: Navelbine;Drug: Gemcitabine<br>* Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles<br>* Other names: Gemzar;|
| Experimental: 2<br>DG | Drug: Docetaxel<br>* Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles<br>* Other names: Taxotere;Drug: Gemcitabine<br>* Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | 
| Time to tumor progression |  | 1 year | 
| Toxicity |  | Toxicity assessment on each chemotherapy cycle | 
| Quality of life |  | Assessment every two cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, 1st line treatment, Gemcitabine, Vinorelbine, Docetaxel