Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Advanced Vaginal Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan
- Patient must provide study specific informed consent prior to study entry
- Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent
- Absolute neutrophil count > 1,500/uL
- Platelets > 100,000/uL
- Hemoglobin > 10 g/dL
- Total bilirubin < 2.0 mg/dL
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
- Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal
Creatinine =< 1.5 mg/dL to receive weekly cisplatin
- Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used
- Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)
- Patient has a life expectancy of greater than 20 weeks
- Patient does not have known brain metastases (testing optional)
- Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with triapine
- Patient does not have a known allergy to compounds of similar or biologic composition as triapine
- Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism (G6PD testing optional)
- Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)
Exclusion Criteria:
- Patient has another concurrent active invasive malignancy
- Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician
- Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements
- Patient is receiving another investigational agent for the treatment of cancer
- Patient is currently pregnant
- Patient does not agree to use two forms of birth control if they are of child-bearing potential
- Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible (05/30/2017)
- Patients scheduled to be treated with adjuvant consolidation chemotherapy or other anti-neoplastic therapy at the conclusion of their standard chemoradiation (05/30/2017)
- Patients with self-reported or known diagnosis of G6PD deficiency (05/30/2017)
- Patients with vaginal cancer may have previously undergone a hysterectomy for various indications; patients with vaginal cancer who underwent a hysterectomy for treatment of cervical cancer less than five years prior to their diagnosis of vaginal cancer are ineligible
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Anchorage Associates in Radiation Medicine
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- CHI Saint Vincent Cancer Center Hot Springs
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Deer Valley Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Kaiser Permanente-Fremont
- Kaiser Permanente-Fresno
- UC San Diego Moores Cancer Center
- Los Angeles County-USC Medical Center
- Kaiser Permanente-Modesto
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- UCHealth University of Colorado Hospital
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Longmont United Hospital
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers-Thornton
- Hartford Hospital
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- University of Florida Health Science Center - Gainesville
- Mayo Clinic in Florida
- Lakeland Regional Health Hollis Cancer Center
- Moffitt Cancer Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Augusta University Medical Center
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Saint Luke's Cancer Institute - Twin Falls
- Saint Joseph Medical Center
- Memorial Hospital of Carbondale
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- Northwestern Medicine Cancer Center Warrenville
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- Ascension Saint Vincent Indianapolis Hospital
- Reid Health
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer Center
- Jewish Hospital
- The James Graham Brown Cancer Center at University of Louisville
- UofL Health Medical Center Northeast
- East Jefferson General Hospital
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Greater Baltimore Medical Center
- Walter Reed National Military Medical Center
- Henry Ford Cancer Institute-Downriver
- Henry Ford Macomb Hospital-Clinton Township
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Weisberg Cancer Treatment Center
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Trinity Health Muskegon Hospital
- Spectrum Health Reed City Hospital
- Lakeland Medical Center Saint Joseph
- Munson Medical Center
- Henry Ford West Bloomfield Hospital
- University of Michigan Health - West
- University of Minnesota/Masonic Cancer Center
- Mayo Clinic in Rochester
- University of Mississippi Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Saint Francis Medical Center
- Southeast Cancer Center
- Capital Region Southwest Campus
- Freeman Health System
- North Kansas City Hospital
- The University of Kansas Cancer Center-South
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Kalispell Regional Medical Center
- Community Medical Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Radiation Oncology Centers of Nevada Central
- Women's Cancer Center of Nevada
- Center of Hope at Renown Medical Center
- Renown Regional Medical Center
- Cooper Hospital University Medical Center
- Virtua Memorial
- Cooper CyberKnife Center
- Rutgers Cancer Institute of New Jersey
- Rutgers New Jersey Medical School
- Robert Wood Johnson University Hospital Somerset
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua Voorhees
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Memorial Medical Center - Las Cruces
- Saint Peter's Health Partners
- Women's Cancer Care Associates LLC
- Maimonides Medical Center
- Roswell Park Cancer Institute
- Mount Sinai Chelsea
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Highland Hospital
- University of Rochester
- State University of New York Upstate Medical University
- Novant Health Presbyterian Medical Center
- Wake Forest University Health Sciences
- Summa Health System - Akron Campus
- UHHS-Chagrin Highlands Medical Center
- Aultman Health Foundation
- Miami Valley Hospital South
- Geauga Hospital
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Mount Carmel East Hospital
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical Center
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Bay Area Hospital
- Legacy Mount Hood Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Oregon Health and Science University
- Legacy Meridian Park Hospital
- Jefferson Abington Hospital
- UPMC-Heritage Valley Health System Beaver
- Christiana Care Health System-Concord Health Center
- Northeast Radiation Oncology Center
- Ephrata Cancer Center
- Adams Cancer Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Cherry Tree Cancer Center
- UPMC Hillman Cancer Center in Coraopolis
- Thomas Jefferson University Hospital
- UPMC-Magee Womens Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- Reading Hospital
- Asplundh Cancer Pavilion
- Lankenau Medical Center
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- Women and Infants Hospital
- Saint Francis Hospital
- Prisma Health Cancer Institute - Faris
- Saint Francis Cancer Center
- Spartanburg Medical Center
- Rapid City Regional Hospital
- Memorial Hospital
- Vanderbilt University/Ingram Cancer Center
- Saint Joseph Regional Cancer Center
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Houston Methodist Hospital
- Memorial Hermann Texas Medical Center
- Methodist Willowbrook Hospital
- Houston Methodist Sugar Land Hospital
- Houston Methodist The Woodlands Hospital
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- South Jordan Health Center
- Providence Regional Cancer System-Aberdeen
- MultiCare Auburn Medical Center
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Providence Regional Cancer Partnership
- Virginia Mason Federal Way Medical Center
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- Providence Regional Cancer System-Lacey
- PeaceHealth Saint John Medical Center
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Virginia Mason Medical Center
- FHCC South Lake Union
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- PeaceHealth Southwest Medical Center
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Edwards Comprehensive Cancer Center
- West Virginia University Healthcare
- Wheeling Hospital/Schiffler Cancer Center
- Marshfield Medical Center-EC Cancer Center
- University of Wisconsin Carbone Cancer Center
- Marshfield Medical Center-Marshfield
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- Marshfield Medical Center-River Region at Stevens Point
- Marshfield Medical Center - Weston
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- San Juan Community Oncology Group
- Centro Comprensivo de Cancer de UPR
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (cisplatin, IMRT or RT, brachytherapy)
Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.