Status:
TERMINATED
Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Nasser Hanna, M.D.
Collaborating Sponsors:
Bayer
Amgen
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Outline: This is a multi-center study. Chemotherapy/radiation therapy (2 cycles) * Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle * Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle * Concurrent ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00417248
Start Date
June 1 2007
End Date
April 1 2008
Last Update
July 25 2016
Active Locations (8)
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1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
3
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
4
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202