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Sponsors and Collaborators: |
Hoosier Oncology Group Bayer ONYX Pharmaceuticals Walther Cancer Institute |
Information provided by: | Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00417248 |
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.
Condition | Intervention | Phase |
Non-Small Cell Lung Cancer |
Drug: Cisplatin Drug: Etoposide Procedure: Radiotherapy Drug: Sorafenib |
Phase I Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Etoposide Cisplatin Sorafenib Sorafenib tosylate Etoposide phosphate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Concurrent Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN06-107 |
Enrollment: | 12 |
Study Start Date: | June 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Cisplatin/Etoposide/Radiotherapy Followed By Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer
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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.
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OUTLINE: This is a multi-center study.
CHEMOTHERAPY/RADIATION THERAPY (2 cycles)
Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.
Patients with progressive disease will discontinue treatment.
ECOG performance status 0 or 1
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Respiratory:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |||||
Medical & Surgical Specialists, LLC | |||||
Galesburg, Illinois, United States, 61401 | |||||
United States, Indiana | |||||
Indiana University Cancer Center | |||||
Indianapolis, Indiana, United States, 46202 | |||||
Medical Consultants, P.C. | |||||
Muncie, Indiana, United States, 47303 | |||||
Center for Cancer Care at Goshen Health System | |||||
Goshen, Indiana, United States, 46527 | |||||
Fort Wayne Oncology & Hematology, Inc | |||||
Fort Wayne, Indiana, United States, 46815 | |||||
Horizon Oncology Center | |||||
Lafayette, Indiana, United States, 47905 | |||||
Northern Indiana Cancer Research Consortium | |||||
South Bend, Indiana, United States, 46601 | |||||
United States, Ohio | |||||
Oncology Partners Network | |||||
Cincinnati, Ohio, United States, 45247 |
Hoosier Oncology Group |
Bayer |
ONYX Pharmaceuticals |
Walther Cancer Institute |
Study Chair: | Nasser Hanna, M.D. | Hoosier Oncology Group, LLC |
Hoosier Oncology Group Home Page 
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Responsible Party: | Hoosier Oncology Group ( Nasser Hanna, M.D. ) |
Study ID Numbers: | HOG LUN06-107 |
First Received: | December 28, 2006 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00417248 |
Health Authority: | United States: Institutional Review Board |
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