Status:
COMPLETED
Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Pharmacia and Upjohn
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with...
Detailed Description
Upon determination of eligibility, all patients will be receive: * Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab Patients will receive 4 courses of irinotecan/carboplatin. Radiation the...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Small cell lung cancer, confirmed by biopsy.
- Limited stage disease after standard evaluation.
- Able to perform activities of daily living without assistance.
- No previous treatment with chemotherapy, radiation therapy, or biologics.
- Measurable or evaluable disease
- Adequate bone marrow, liver and kidney function
- Able to understand the nature of this study and give written consent.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Age \< 18 years
- History of previous malignancies
- Women pregnant or lactating
- History or physical exam evidence of central nervous system disease)
- Active infection requiring intravenous antibiotics
- Full-dose anticoagulation or thrombolytic therapy within 10 days
- Proteinuria.
- Serious nonhealing wound, ulcer, or bone fracture
- Evidence if bleeding diathesis or coagulopathy
- History of heart attack within 6 months.
- Uncontrolled cardiovascular disease
- PEG or G-tube
- History of other serious disease
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00193375
Start Date
August 1 2003
End Date
May 1 2008
Last Update
August 10 2016
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