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Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer

NCT00417248 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-07-25

Study results available
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Summary

Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.

Conditions

Interventions

DRUG

Cisplatin

Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle

DRUG

Etoposide

Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle

PROCEDURE

Radiotherapy

Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)

DRUG

Sorafenib

Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Nasser Hanna, M.D.

    lead OTHER

Principal Investigators

  • Nasser Hanna, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00417248 on ClinicalTrials.gov