Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Small Cell Lung, Lung Cancer
Trial Information
Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer
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 chemotherapy courses will be 28 days.Patients will be completely restaged
approximately 2 weeks after completion of chemotherapy prior to beginning treatment with
maintenance bevacizumab. Those with progressive tumor or serious toxicity will come off
study. Those with stable disease or objective tumor responses will continue treatment with
restaging every 12 weeks for a minimum of 6 cycles (6 months).
- Induction chemotherapy regimen Irinotecan: 60mg/m2 IV on days 1, 8, and 15 Carboplatin:
AUC=4 day 1 only Bevacizumab 10 mg/kg IV days 1, 15 Cycles are repeated every 28 days
for four courses
- Radiation therapy 1.8 Gy, single daily fractions, concurrently with the third course of
chemotherapy e to a total dose of 61.2 Gy (34 fractions). Patients obtaining complete
remission or near complete remission will also receive prophylactic whole brain
radiotherapy, given within one month after all therapy is completed (total dose 24Gy in
2Gy daily fractions).
- Maintenance Bevacizumab Bevacizumab alone at a dose of 10 mg/kg IV days 1 and 15 each
cycle, for a maximum of 6 additional cycles (6 months) with restaging every 12 weeks.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
progression-free survival
Principal Investigator
David R. Spigel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
SCRI LUN 110
NCT ID:
NCT00308529
Start Date:
March 2006
Completion Date:
January 2009
Related Keywords:
- Carcinoma, Small Cell Lung
- Lung Cancer
- Carcinoma Small Cell Lung
- Lung Cancer
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Small Cell
Name | Location |
|---|---|
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| Oncology Hematology Care | Cincinnati, Ohio 45242 |
| Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
