449
Participants
Start Date
September 17, 2002
Primary Completion Date
June 30, 2009
filgrastim
250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
sargramostim
5 μg/kg/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
cytarabine
100 mg/m²/day by continuous intravenous infusion for 7 days (days 1-7).
daunorubicin hydrochloride
45 mg/m²/day by 10 - 15 minute intravenous infusion for 3 days (days 1, 2, and 3).
zosuquidar trihydrochloride
"Zosuquidar 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3.~The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3."
Placebo
"Placebo 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3.~The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. Placebo consisted of a 1:1000 dilution of Infuvite, appropriately colored."
NYU Cancer Institute at New York University Medical Center, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, The Bronx
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh
Geisinger Medical Group, State College
St. Luke's Hospital Cancer Center, Bethlehem
Hematology and Oncology Associates, Scranton
Geisinger Wyoming Valley Medical Center, Wilkes-Barre
Guthrie Medical Center - Sayre, Sayre
Abramson Cancer Center of the University of Pennsylvania, Philadelphia
University of Virginia Cancer Center, Charlottesville
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville
MBCCOP-Medical College of Georgia Cancer Center, Augusta
Baptist Cancer Institute - Jacksonville, Jacksonville
University of Florida Shands Cancer Center, Gainesville
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa
Watson Clinic, LLC, Lakeland
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland
Aultman Hospital Cancer Center at Aultman Health Foundation, Canton
Indiana University Cancer Center, Indianapolis
Methodist Cancer Center at Methodist Hospital, Indianapolis
CCOP - Michigan Cancer Research Consortium, Ann Arbor
Borgess Medical Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
McFarland Clinic, P.C., Ames
Siouxland Hematology-Oncology Associates, Sioux City
St. Luke's Regional Medical Center, Sioux City
University of Wisconsin Comprehensive Cancer Center, Madison
Marshfield Clinic - Marshfield Center, Marshfield
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse
United Hospital, Saint Paul
Fairview Ridges Hospital, Burnsville
Ridgeview Medical Center, Waconia
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis
CCOP - Metro-Minnesota, Saint Louis Park
Park Nicollet Clinic, Saint Louis Park
Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale
Mercy and Unity Cancer Center at Unity Hospital, Fridley
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids
Fairview Southdale Hospital, Edina
Mayo Clinic Cancer Center, Rochester
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls
Evanston Northwestern Health Care - Evanston Hospital, Evanston
Hematology and Oncology Associates, Chicago
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago
Rush University Medical Center, Chicago
Carle Cancer Center at Carle Foundation Hospital, Urbana
Decatur Memorial Hospital Cancer Care Institute, Decatur
Cancer Center of Kansas - Chanute, Chanute
Cancer Center of Kansas - Salina, Salina
Cancer Center of Kansas - Kingman, Kingman
Cancer Center of Kansas - Newton, Newton
Pratt Cancer Center of Kansas, Pratt
Cancer Center of Kansas - Wellington, Wellington
Cancer Center of Kansas - Winfield, Winfield
Associates in Womens Health, Wichita
Cancer Center of Kansas, P.A., Wichita
Cancer Center of Kansas, P.A. - Wichita, Wichita
CCOP - Wichita, Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita
Wesley Medical Center, Wichita
Cancer Center of Kansas - Dodge City, Dodge City
Southwest Medical Center, Liberal
Aurora Presbyterian Hospital, Aurora
Swedish Medical Center, Englewood
Sky Ridge Medical Center, Lone Tree
Porter Adventist Hospital, Denver
Presbyterian - St. Luke's Medical Center, Denver
St. Joseph Hospital, Denver
Rose Medical Center, Denver
North Suburban Medical Center, Thornton
Boulder Community Hospital, Boulder
Hope Cancer Care Center at Longmont United Hospital, Longmont
Penrose Cancer Center at Penrose Hospital, Colorado Springs
St. Mary-Corwin Regional Medical Center, Pueblo
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale
University Medical Center of Southern Nevada, Las Vegas
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas
CCOP - Colorado Cancer Research Program, Incorporated, Denver
Mayo Clinic - Jacksonville, Jacksonville
Regional Cancer Center at Memorial Medical Center, Springfield
Tufts - New England Medical Center, Boston
Beth Israel Deaconess Medical Center, Boston
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor
CCOP - Northern New Jersey, Hackensack
Booker Cancer Center at Riverview Medical Center, Red Bank
Geisinger Medical Center, Danville
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey
Rambam Medical Center, Haifa
Collaborators (1)
National Cancer Institute (NCI)
NIH
Eli Lilly and Company
INDUSTRY
Kanisa Pharmaceuticals
INDUSTRY
Eastern Cooperative Oncology Group
NETWORK