Advanced Non-Small Cell Lung Cancer
Conditions
Brief summary
To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.
Detailed description
The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.
Interventions
DRUGDocetaxel
Sponsors
Gachon University Gil Medical Center
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 proven non-small cell lung cancer * no prior chemotherapy or only adjuvant chemotherapy which had been completed \>6 months before registration * ECOG performance status 0 to 2 * measurable lesion(s) * normal marrow, hepatic and renal functions * provision of written informed consent
Exclusion criteria
* active infection or severe comorbidities * history of anaphylaxis of any origin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Overall survival | — |
| Safety | — |
Countries
South Korea
Outcome results
None listed