Non-Small Cell Lung Cancer Clinical Trial
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
Verified date | April 2011 |
Source | Hoosier Cancer Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological or cytological proof of non-small cell lung cancer (NSCLC). - Measurable or non-measurable disease per RECIST. - Unresectable Stage IIIA or IIIB disease as evaluated by imaging. - Must be age = 18 years at the time of consent. - Written informed consent and HIPAA authorization for release of personal health information. - Females of childbearing potential and males must be willing to use an effective method of contraception. - Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for initial therapy. Exclusion Criteria: - No prior chemotherapy or radiotherapy for lung cancer. - No positive supraclavicular or scalene lymph nodes extending up into the cervical region. - No superior sulcus (pancoast tumors). - No malignant pleural effusions. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap. - No clinically significant or malignant pericardial effusions. - No CNS metastases. - No unintended weight loss (> 5% body weight) in the preceding 90 days prior to registration for initial therapy. - No treatment with any investigational agent within 30 days prior to being registered for initial therapy. - No prior therapy with a Ras pathway inhibitor or anti-angiogenic agent. - No other active cancers. - Females must not be breastfeeding. - No active clinically serious infections as judged by the treating investigator (> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C. - No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for initial therapy. - No anticipation of need for major surgical procedure during the course of the study. - No minor surgical procedures such as fine needle aspirations or cone biopsies within 7 days prior to registration for initial therapy. - No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 + polyethylene glycol (etoposide). - No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for initial therapy. - No use inhibitors or inducers of the cytochrome p450 system CYP3A4 enzyme or other medications such as aprepitant, ketoconazole, itraconazole, quinidine, digoxin, cyclosporine, ritonavir, grapefruit products, St. John's Wort, rifampin (rifampicin), carbamazepine, phenytoin, dexamethasone, and phenobarbital. - No evidence or history of bleeding diathesis or coagulopathy. - No serious non-healing wound, ulcer, or bone fracture. - No known or suspected allergy to sorafenib. - No uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management. - No thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within 6 months prior to registration for initial therapy. - No pulmonary hemorrhage/bleeding event = CTCAE Grade 2 within 4 weeks prior to registration for initial therapy. - No hemorrhage/bleeding event = CTCAE Grade 3 within 4 weeks prior to registration for initial therapy. - No condition that impairs patient's ability to swallow whole pills or any malabsorption problem. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Oncology Partners Network | Cincinnati | Ohio |
United States | Fort Wayne Oncology & Hematology, Inc | Fort Wayne | Indiana |
United States | Medical & Surgical Specialists, LLC | Galesburg | Illinois |
United States | Center for Cancer Care at Goshen Health System | Goshen | Indiana |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | Horizon Oncology Center | Lafayette | Indiana |
United States | Medical Consultants, P.C. | Muncie | Indiana |
United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
Lead Sponsor | Collaborator |
---|---|
Hoosier Cancer Research Network | Bayer, Onyx Pharmaceuticals, Walther Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective is to determine the time to disease progression | 18 months | No | |
Secondary | The secondary objectives include: further characterization of the safety and toxicity of this regimen as well as median overall survival | 18 months | Yes |
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