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

NCT00682383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-10-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Mt. Sinai Medical Center, Miami

    lead OTHER

Principal Investigators

  • Rogerio Lilenbaum, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682383 on ClinicalTrials.gov