Phase 2
N=60
Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00193375 ↗Enrolled (actual)
60
Serious AEs
58.3%
Results posted
Nov 2012
Primary outcome: Primary: Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) — 2; 1; 1; 1 Grade 3/4 Toxicity Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Irinotecan (Drug); Carboplatin (Drug); Bevacizumab (Drug); Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) |
2; 1; 1; 1; 1; 4 | — |
| SECONDARY 2-Year Progression-free Survival (PFS) |
22 | — |
| SECONDARY Overall Response Rate |
80 | — |
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 limited stage small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00193375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.