Home
Search
Study Topics
Glossary
|
|
|
|
|
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 |
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
|
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
|
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:
John's Wort, rifampin (rifampicin), carbamazepine, phenytoin, dexamethasone, and phenobarbital.
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 |
Study Chair: | Nasser Hanna, M.D. | Hoosier Oncology Group, LLC |
Responsible Party: | Hoosier Oncology Group ( Nasser Hanna, M.D. ) |
Study ID Numbers: | HOG LUN06-107 |
Study First Received: | December 28, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00417248 History of Changes |
Health Authority: | United States: Institutional Review Board |
Thoracic Neoplasms Protein Kinase Inhibitors Etoposide phosphate Carcinoma Respiratory Tract Diseases Cisplatin Radiation-Sensitizing Agents Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Sorafenib Etoposide Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Etoposide phosphate Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Antineoplastic Agents, Phytogenic Etoposide Carcinoma, Non-Small-Cell Lung Sorafenib Neoplasms, Glandular and Epithelial |