NCT00682383

Combined Modality Therapy With Growth Factor Support in Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Phase II Trial of Combined Modality Therapy With Growth Factor Support in Locally Advanced NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of administering filgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients.

Conditions

• Unresectable Locally Advanced NSCLC

Interventions

Type	Name	Description
DRUG	Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta	Cisplatin 75 mg/m2 day 1 and 22 Etoposide 80mg/m2 days 1-3, 22-24 Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days) Filgrastim 5µg/kg\* SQ injection days 4-13 and days 25-34 Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles Pegfilgrastim 6 mg SQ injection day 2 of each cycle

Timeline

• Start date: 2003-09-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-05-22
• Last updated: 2012-10-30

Locations

1 site across 1 country: United States