Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC, 1st line treatment, Gemcitabine, Vinorelbine, Docetaxel
Brief 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.
Detailed 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.
Interventions
DRUGVinorelbine
Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
DRUGGemcitabine
Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
DRUGDocetaxel
Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
Secondary
| Measure | 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 |
Countries
Greece
Outcome results
None listed