A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer
OBJECTIVES:
I. Determine the overall survival of patients with limited stage small cell lung cancer
treated with tirapazamine, cisplatin, and etoposide with concurrent thoracic radiotherapy
followed by consolidation cisplatin and etoposide.
II. Determine the time to treatment failure and response (confirmed and unconfirmed,
complete and partial) in patients with measurable disease treated with this regimen.
III. Determine the toxicity of this regimen in these patients. IV. Correlate baseline PAI-1,
VEGF, OPN, and NDRG1 plasma markers with response and survival of patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Chemoradiotherapy: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29,
36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1
hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic
radiotherapy once daily 5 days a week for 7 weeks.
Consolidation chemotherapy: Within 28 days after completion of radiotherapy, patients with
stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide
IV over 1 hour on days 1-3 and 22-24.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17
months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.
Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.
No
Quynh-Thu X. Le, MD
Study Chair
Stanford University
United States: Federal Government
NCI-2012-03042
NCT00066742
September 2003
August 2009
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Wesley Medical Center | Wichita, Kansas 67214 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
Great Falls Clinic | Great Falls, Montana 59405 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Southwest Medical Center | Liberal, Kansas 67901 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Salina Regional Health Center | Salina, Kansas 67401 |
Stormont-Vail Cancer Center | Topeka, Kansas 66604 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Adirondack Cancer Care - Glens Falls | Glens Falls, New York 12801 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Mercy Medical Center | Springfield, Ohio 45504 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Washington Hematology-Oncology Specialists | Yakima, Washington 98902 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Capital Medical Center | Olympia, Washington 98502 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
St. Joseph Medical Center at Franciscan Health System | Tacoma, Washington 98405-3004 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
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 |
Salem Hospital Regional Cancer Care Services | Salem, Oregon 97309-5014 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
St. Joseph Hospital Regional Cancer Center - Orange | Orange, California 92868-3849 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Highlands Oncology Group - Springdale | Springdale, Arkansas 72764 |
Caritas St. Elizabeth's Medical Center | Brighton, Massachusetts 02135-2997 |
Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens, Michigan 48043 |
Providence Centralia Hospital Regional Cancer Center | Centralia, Washington 98531 |
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital | Grass Valley, California 95945 |