Status:
COMPLETED
Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Carcinoma, Small Cell Lung
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This proposed phase II trial will investigate the combination of irinotecan, carboplatin and bevacizumab along with radiation in the treatment of patients with limited-stage SCLC. This study differs f...
Detailed Description
Eligible patients will receive 4 courses of irinotecan, carboplatin, and bevacizumab. Radiation therapy will begin concurrently with the third course of systemic treatment. The intervals between chemo...
Eligibility Criteria
Inclusion
- Histologically-confirmed small cell lung cancer.
- Limited stage disease (
- ECOG performance status 0 or 1.
- No previous treatment with chemotherapy, radiation therapy, or biologic agents.
- Measurable disease
- Adequate bone marrow, liver, kidney function
- Patients must be able to understand the nature of this study and give written consent.
Exclusion
- Age \< 18 years
- History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma, or early stage prostate cancer.
- Women who are pregnant or lactating are ineligible. Men and women of childbearing potential are required to use adequate contraception during this study.
- History or physical exam evidence of CNS disease (eg seizures not controlled with standard medical therapy, history of stroke)
- Active infection requiring parenteral antibiotics
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or fine needle aspiration within 7 days of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study.
- Full-dose oral or parenteral anticoagulation must be on a stable dosing schedule prior to enrollment.
- Proteinuria
- Serious nonhealing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- Prior hemoptysis.
- History of acute myocardial infarction or stroke within 6 months
- Uncontrolled hypertension (\> 150/100), unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease.
- Received other investigational drugs within 28 days
- PEG, G-tubes, or other percutaneous drains/tubes
- History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or place the subject at high risk for treatment complications
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the previous 6 months
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00308529
Start Date
March 1 2006
End Date
January 1 2009
Last Update
June 22 2010
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
3
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
4
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023