Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer
Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer
2 other identifiers
interventional
55
1 country
4
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 from our "maintenance" bevacizumab trial in that bevacizumab will begin with the initial chemotherapy treatment. Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. Adding a novel minimally toxic agent to this regimen up front may further enhance this doublet's efficacy without contributing to toxicity. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy and chemotherapy in the up front treatment of a common solid tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2006
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJune 22, 2010
January 1, 2009
1.1 years
March 27, 2006
June 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
Secondary Outcomes (4)
toxicity
overall response rate
duration of response
overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
Study Sites (4)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related Publications (1)
Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9.
PMID: 19901100RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R. Spigel, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 29, 2006
Study Start
March 1, 2006
Primary Completion
April 1, 2007
Study Completion
January 1, 2009
Last Updated
June 22, 2010
Record last verified: 2009-01