NCT00291850

Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC

Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.

Detailed description

This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC. Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines. Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle. All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel, Cisplatin, Pegfilgrastim

Timeline

• Start date: 2005-06-01
• First posted: 2006-02-15
• Last updated: 2012-05-01

Locations

5 sites across 3 countries: Austria, Hungary, Poland