Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Cervical Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix Stage IB2, IIA, IIB, IIIB, or IVA disease Stage IIA tumors must be > 4 cm Primary, untreated disease Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or lymphadenectomy Must have been adequately clinically staged Suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiotherapy No disease involvement of the lower third of the vagina regardless of stage (all stage IIIA, IIIB and IVA with lower one-third involvement) No carcinoma of the cervical stump Performance status - GOG 0-3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 3 times ULN Alkaline phosphatase ≤ 3 times ULN Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min No New York Heart Association class III-IV heart failure No history of myocardial infarction No unstable angina No uncontrolled hypertension No pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No septicemia or severe infection No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy No prior coronary artery bypass surgery No prior cancer therapy that would preclude study treatment No concurrent angina medication No concurrent intensity-modulated radiotherapy
Sites / Locations
- University of Alabama at Birmingham
- Mobile Infirmary Medical Center
- Providence Alaska Medical Center
- Banner Good Samaritan Medical Center
- Western Regional CCOP
- Highlands Oncology Group PA - Fayetteville
- Washington Regional Medical Center - Fayetteville
- University of Arkansas for Medical Sciences
- East Bay Radiation Oncology Center
- City of Hope Medical Center
- Jonsson Comprehensive Cancer Center
- Bay Area Tumor Institute CCOP
- University of California Medical Center At Irvine-Orange Campus
- Pomona Valley Hospital Medical Center
- Stanford University Hospitals and Clinics
- Olive View-University of California Los Angeles Medical Center
- Colorado Gynecologic Oncology Group
- Memorial Hospital Colorado Springs
- North Colorado Medical Center
- McKee Medical Center
- Hartford Hospital
- The Hospital of Central Connecticut
- Yale University
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Washington Hospital Center
- Florida Gynecologic Oncology
- Mayo Clinic in Florida
- UF Cancer Center at Orlando Health
- Piedmont Hospital
- Northside Hospital
- Saint Joseph's Hospital of Atlanta
- Georgia Regents University
- John B Amos Cancer Center
- Dekalb Medical Center
- Wellstar Kennestone Hospital
- Memorial Health University Medical Center
- Pali Momi Medical Center
- Hawaii Minority Based CCOP
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii
- The Cancer Center of Hawaii-Liliha
- Tripler Army Medical Center
- Maui Memorial Medical Center
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Rush University Medical Center
- University of Illinois
- University of Chicago
- Saint Francis Hospital
- Western Illinois Cancer Treatment Center
- Joliet Oncology-Hematology Associates Limited
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Advocate Lutheran General Hospital.
- Illinois CancerCare-Peoria
- OSF Saint Francis Medical Center
- Valley Radiation Oncology
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Carle Clinic-Urbana Main
- Elkhart General Hospital
- Indiana University Medical Center
- Gynecologic Oncology of Indiana
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Saint Joseph Regional Medical Center-Mishawaka
- Memorial Hospital of South Bend
- Northern Indiana Cancer Research Consortium
- McFarland Clinic PC-William R Bliss Cancer Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa Hospitals and Clinics
- Siouxland Hematology Oncology Associates
- Hospital District Sixth of Harper County
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Providence Medical Center
- University of Kansas Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas - Newton
- Radiation Oncology Practice Corporation Southwest
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wesley Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Saint Elizabeth Medical Center South
- The James Graham Brown Cancer Center at University of Louisville
- Tulane University Health Sciences Center
- Louisiana State University Health Sciences Center Shreveport
- Eastern Maine Medical Center
- Maine Medical Center-Bramhall Campus
- Union Hospital of Cecil County
- University of Massachusetts Medical School
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Wayne State University/Karmanos Cancer Institute
- Green Bay Oncology - Escanaba
- Grand Rapids Clinical Oncology Program
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Spectrum Health-Blodgett Campus
- Gynecologic Oncology of West Michigan PLLC
- Green Bay Oncology - Iron Mountain
- Mercy Health Partners-Hackley Campus
- Mercy Health Mercy Campus
- William Beaumont Hospital-Royal Oak
- Lakeland Hospital
- Providence Hospital
- Munson Medical Center
- Metro Health Hospital
- Mayo Clinic
- Saint Francis Regional Medical Center
- University of Mississippi Medical Center
- University of Missouri - Ellis Fischel
- Centerpoint Medical Center LLC
- Radiation Oncology Practice Corporation South
- Radiation Oncology Practice Corporation - North
- Saint Louis University Hospital
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- Saint John's Mercy Medical Center
- Mercy Hospital Springfield
- Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
- CoxHealth South Hospital
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Hematology-Oncology Centers of the Northern Rockies PC
- Billings Clinic
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Good Samaritan Hospital
- Nebraska Methodist Hospital
- University of Nebraska Medical Center
- Center of Hope at Renown Medical Center
- Renown Regional Medical Center
- Cooper Hospital University Medical Center
- Mountainside Hospital
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Jersey Shore Medical Center
- Rutgers Cancer Institute of New Jersey
- UMDNJ - New Jersey Medical School
- Community Medical Center
- Virtua West Jersey Hospital Voorhees
- University of New Mexico Cancer Center
- Women's Cancer Care Associates LLC
- Island Gynecologic Oncology
- Montefiore Medical Center-Weiler Division
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Queens Hospital Center
- North Shore University Hospital
- North Shore-LIJ Health System CCOP
- Orange Regional Medical Center
- Long Island Jewish Medical Center
- North Shore-LIJ Health System/Center for Advanced Medicine
- New York University Langone Medical Center
- Memorial Sloan-Kettering Cancer Center
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Good Samaritan Hospital Medical Center
- Hope Women's Cancer Centers-Asheville
- University of North Carolina
- Duke University Medical Center
- New Hanover Regional Medical Center
- Wilson Medical Center
- Wake Forest University Health Sciences
- Bismarck Cancer Center
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Akron General Medical Center
- Aultman Health Foundation
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- University of Cincinnati
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Riverside Methodist Hospital
- Mount Carmel Health Center West
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Hillcrest Hospital Cancer Center
- Lake University Ireland Cancer Center
- Wright-Patterson Medical Center
- University of Oklahoma Health Sciences Center
- Cancer Care Associates-Midtown
- Tulsa Cancer Institute
- Salem Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital
- Saint Luke's University Hospital-Bethlehem Campus
- Lancaster General Hospital
- Thomas Jefferson University Hospital
- Magee-Womens Hospital of UPMC
- Western Pennsylvania Hospital
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Scranton Hematology Oncology
- Reading Hospital
- Women and Infants Hospital
- Medical University of South Carolina
- Black Hills Obstetrics and Gynecology
- Chattanooga Gynecological Oncology
- Chattanooga's Program in Women's Oncology
- East Tennessee State University
- Meharry Medical College
- Vanderbilt-Ingram Cancer Center
- The Don and Sybil Harrington Cancer Center
- University of Texas Southwestern Medical Center
- Brooke Army Medical Center
- University of Texas Medical Branch at Galveston
- M D Anderson Cancer Center
- Doctor's Hospital of Laredo
- Texas Tech University Health Sciences Center
- American Fork Hospital
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Fletcher Allen Health Care-Medical Center
- Northern Virginia Pelvic Surgery Associates
- University of Virginia
- Bon Secours Mary Immaculate Hospital
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University
- Carilion Clinic Gynecological Oncology
- Good Samaritan Community Hospital
- University of Washington Medical Center
- Northwest CCOP
- Northwest Medical Specialties PLLC
- Saint Joseph Medical Center
- Tacoma General Hospital
- Multicare Health System
- Wheeling Hospital
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Bay Area Medical Center
- Froedtert and the Medical College of Wisconsin
- Green Bay Oncology - Oconto Falls
- Green Bay Oncology - Sturgeon Bay
- Aurora West Allis Medical Center
- Tom Baker Cancer Centre
- BCCA-Fraser Valley Cancer Centre
- BCCA-Vancouver Cancer Centre
- Health Sciences North
- Thunder Bay Regional Health Science Centre
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- CHUM - Hopital Notre-Dame
- CHUQ - Pavilion Hotel-Dieu de Quebec
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (cisplatin)
Arm II (cisplatin, tirapazamine)
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.