Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study
OUTLINE: This is a multi-center study.
Paclitaxel 90 mg/m2 IV infusion over 1 hour days 1, 8 and 15 of 28 day cycle
Plus
Bevacizumab 10 mg/kg on days 1 and 15 of 28 day cycle.
- 1 cycle = 28 days (4 weeks)
- Disease assessments will be performed per RECIST every other cycle
- After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy,
bevacizumab monotherapy may continue until disease progression or intolerable side
effects
ECOG Performance Status 0 or 1
Hematopoietic:
- White blood cell count > 3,000 mm3
- Absolute neutrophil count (ANC) > 1,500 mm3
- Platelet count > 100,000 mm3
- International normalized ration (INR) of prothrombin time ≤ 1.2
- PTT no more than 5 seconds longer than the ULN
Hepatic:
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN
Renal:
- Urine protein:creatinine ratio <1.0
Cardiovascular:
- No history of myocardial infarction or angina pectoris/anginal equivalent in the last 6
months. Note: The patient may be on anti-anginal medications if the symptoms have
been entirely controlled for greater than 6 months.
- No history of uncontrolled congestive heart failure or uncontrolled hypertension
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).
18 months
No
Nasser Hanna, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Food and Drug Administration
HOG LUN05-99
NCT00317200
April 2006
November 2007
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Community Regional Cancer Center | Indianapolis, Indiana 46256 |
Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Center for Cancer Care, Inc., P.C. | New Albany, Indiana 47150 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Pennsylvania Oncology-Hematology Associates | Philadelphia, Pennsylvania 19106 |
Fox Chase Cancer Center Extramural Research Program | Rockledge, Pennsylvania 19046 |