A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of topotecan hydrochloride with vs without aflibercept
(ziv-aflibercept), in terms of progression-free survival at 3 months, in patients with
extensive stage small cell lung cancer previously treated with platinum-based therapy.
SECONDARY OBEJCTIVES:
I. Assess the response rate (confirmed and unconfirmed, complete and partial responses) in a
subset of patients with measurable disease.
II. Assess the overall survival of these patients. III. Evaluate the frequency and severity
of toxicities of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
platinum-based therapy (platinum-sensitive disease vs platinum-refractory disease). Patients
are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride
IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in
the absence of disease progression or unacceptable toxicity. Patients with responsive or
stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan
hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
ARM II: Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then
receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for up to 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 months
No
Jeffrey Allen
Principal Investigator
Southwest Oncology Group (SWOG) Research Base
United States: Food and Drug Administration
NCI-2009-01182
NCT00828139
May 2009
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Loyola University Medical Center | Maywood, Illinois 60153 |
South Georgia Medical Center | Valdosta, Georgia 31603 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Akron General Medical Center | Akron, Ohio 44302 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Boston Medical Center | Boston, Massachusetts 02118 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Winthrop University Hospital | Mineola, New York 11501 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Big Sky Oncology | Great Falls, Montana 59405 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
City of Hope Medical Center | Duarte, California 91010 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Grandview Hospital | Dayton, Ohio 45405 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Highland General Hospital | Oakland, California 94602 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Ben Taub General Hospital | Houston, Texas 77030 |
Methodist Hospital | Houston, Texas 77030 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Memorial Medical Center | Springfield, Illinois 62781 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Providence Hospital | Mobile, Alabama 36608 |
Northwest Cancer Specialists | Vancouver, Washington 98664 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
University of Rochester | Rochester, New York 14642 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Southwest Washington Medical Center | Vancouver, Washington 98664 |
El Camino Hospital | Mountain View, California 94040 |
High Point Regional Hospital | High Point, North Carolina 27261 |
Wayne State University | Detroit, Michigan 48202 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Columbus CCOP | Columbus, Ohio 43206 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Oregon Health and Science University | Portland, Oregon 97201 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Louisiana State University Health Science Center | New Orleans, Louisiana 70112 |
Mount Carmel Regional Cancer Center | Pittsburg, Kansas 66762 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
DeKalb Medical Center | Decatur, Georgia 30033 |
Rockwood Clinic | Spokane, Washington 99220 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
San Luis Valley Regional Medical Center | Alamosa, Colorado 81101 |
Valley View Hospital Cancer Center | Glenwood Springs, Colorado 81601 |
Piedmont Fayette Hospital | Fayetteville, Georgia 30214 |
Hays Medical Center | Hays, Kansas 67601 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Providence Newberg Medical Center | Newberg, Oregon 97132 |
Northside Hospital | Atlanta, Georgia 30342 |
Highlands Oncology Group-Bentonville | Bentonville, Arkansas 72712 |
Valley Medical Oncology Consultants-Castro Valley | Castro Valley, California 94546 |
Eden Hospital Medical Center | Castro Valley, California 94546 |
Valley Medical Oncology Consultants-Fremont | Fremont, California 94538 |
Fremont - Rideout Cancer Center | Marysville, California 95901 |
Bay Area Breast Surgeons Inc | Oakland, California 94609 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Tom K Lee Inc | Oakland, California 94609 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Valley Care Health System - Pleasanton | Pleasanton, California 94588 |
Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo, California 94806 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Atlanta Regional CCOP | Atlanta, Georgia 30342 |
Well Star Cobb Hospital | Austell, Georgia 30106 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Saint Anthony's Health | Alton, Illinois 62002 |
Good Samaritan Regional Medical Center | Mt. Vernon, Illinois 62864 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Genesis Medical Center - East Campus | Davenport, Iowa 52803 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Stormont-Vail Regional Health Center | Topeka, Kansas 66604 |
Saint Francis Hospital and Medical Center - Topeka | Topeka, Kansas 66606 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Medical Center of Louisiana | New Orleans, Louisiana 70112 |
Holy Family Hospital | Methuen, Massachusetts 01844 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Kansas City Veterans Affairs Medical Center | Kansas City, Missouri 64128 |
Truman Medical Center | Kansas City, Missouri 64108 |
Saint Louis-Cape Girardeau CCOP | Saint Louis, Missouri 63141 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Saint Louis Cancer and Breast Institute | Saint Louis, Missouri 63109 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Columbia University Medical Center | New York, New York 10032 |
Interlakes Foundation Inc-Rochester | Rochester, New York 14623 |
Highland Hospital | Rochester, New York 14620 |
Gaston Memorial Hospital | Gastonia, North Carolina 28054 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Wright-Patterson Medical Center | Wright-Patterson Afb, Ohio 45433-5529 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Providence Saint Vincent Medical Center | Portland, Oregon 97225 |
Columbia River Oncology Program | Portland, Oregon 97225 |
Salem Hospital | Salem, Oregon 97309 |
AnMed Health Hospital | Anderson, South Carolina 29621 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Veterans Administration Medical Center | Houston, Texas 77030 |
Saint Luke's Episcopal Hospital | Houston, Texas 77030 |
Saint Joseph Hospital | Bellingham, Washington 98225 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Olathe Cancer Center | Olathe, Kansas 66061 |
Lahey Clinic Medical Center | Burlington, Massachusetts 01805 |
NEA Medical Center | Jonesboro, Arkansas 72401 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
The Shaw Regional Cancer Center | Edwards, Colorado 81632 |
Montrose Memorial Hospital | Montrose, Colorado 81401 |
Harbin Clinic Medical Oncology and Clinical Research | Rome, Georgia 30165 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Carolinas Medical Center - Northeast | Concord, North Carolina 28025 |
Moses Cone Health System-Regional Cancer Center | Greensboro, North Carolina 27403 |
Annie Penn Memorial Hospital | Reidsville, North Carolina 27320 |
University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Texas Tech University Health Sciences Center | Lubbock, Texas 79430 |
Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |
Arizona Cancer Center at UMC Orange Grove | Tucson, Arizona 85704 |
Kansas City Cancer Center-West | Kansas City, Kansas 66112 |
Salina Regional Health Center. | Salina, Kansas 67401 |
Arnot Ogden Medical Center | Elmira, New York 14905 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Willamette Falls Community Hospital | Oregon City, Oregon 97045 |
University of Tennessee - Memphis | Memphis, Tennessee 38163 |
Memorial Hospital Of Martinsville | Martinsville, Virginia 24115 |
Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center-Main Campus | Burien, Washington 98166 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Cancer Care Center of Decatur | Decatur, Illinois 62526 |
Gulfport Memorial Hospital | Gulfport, Mississippi 39502 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Promise Regional Medical Center-Hutchinson | Hutchinson, Kansas 65702 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |