A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival of patients with previously untreated
extensive stage small cell lung cancer treated with cisplatin, etoposide, and bevacizumab.
II. Determine the 6-month survival and response rate in patients treated with this regimen.
III. Determine the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Correlate pretreatment plasma levels of vascular endothelial growth factor (VEGF) with
response and progression-free and overall survival of patients treated with this regimen.
II. Correlate elevated plasma levels of endothelial cell-specific proteins (VCAM,
E-selectin) with response in patients treated with this regimen.
III. Correlate pre- and post-treatment plasma levels of basic fibroblast growth factor with
response and progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV
over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the
absence of disease progression or unacceptable toxicity.
Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab
IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year)
in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks for up to 3 years from study entry.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Alive and Progression-free (PF) at 6 Months
Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.
6 months
No
Alan B. Sandler, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
NCI-2012-02944
NCT00079040
June 2004
January 2009
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Southwest Medical Center | Liberal, Kansas 67901 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |