Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
2 other identifiers
interventional
50
1 country
4
Brief Summary
This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.
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 Feb 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
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 20, 2006
CompletedFirst Posted
Study publicly available on registry
February 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJune 28, 2010
January 1, 2009
1.2 years
February 20, 2006
June 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
median time to progression
Secondary Outcomes (4)
overall toxicity
overall response rate
duration of response
overall survival
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed small cell lung cancer,extensive stage disease.
- Measurable or evaluable disease
- No previous chemotherapy
- Able to perform activities of daily living with minimal assistance
- Adequate hematological, live and kidney function
- Provide written informed consent
You may not qualify if:
- Limited stage disease
- PEG or G tubes
- Hemoptysis
- Abdominal fistula, perforation, or abscess within the previous 6 months
- Women who are pregnant or lactating
- Proteinuria
- Serious nonhealing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled or serious cardiovascular disease
- Uncontrolled brain metastasis
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days; Fine needle aspiration within 7 days
- Patients requiring full-dose anticoagulation must be on a stable dosing schedule prior to enrollment
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, Greco FA, Zubkus JD, Murphy PB, Saez RA, Farley C, Yardley DA, Burris HA 3rd, Hainsworth JD. Phase II trial of irinotecan, carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2009 Dec;4(12):1555-60. doi: 10.1097/JTO.0b013e3181bbc540.
PMID: 19875975RESULT
Related Links
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
February 20, 2006
First Posted
February 22, 2006
Study Start
February 1, 2006
Primary Completion
May 1, 2007
Study Completion
January 1, 2009
Last Updated
June 28, 2010
Record last verified: 2009-01