Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
Anal Cancer
About this trial
This is an interventional treatment trial for Anal Cancer focused on measuring squamous cell carcinoma of the anus, stage I anal cancer, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, basaloid carcinoma of the anus, cloacogenic carcinoma of the anus
Eligibility Criteria
INCLUSION CRITERIA: Histologically confirmed anal canal or perianal (anal margin) squamous cell carcinoma Stage I-IIIB (closed to accrual as of 11/3/2008) Stage II (T3, N0 only), IIIA, or IIIB Tumors of nonkeratinizing histology, such as basaloid, transitional cell, or cloacogenic histology, allowed No well-differentiated stage I anal margin cancer Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Hemoglobin ≥ 10 g/dL Platelet count ≥ 100,000/mm^3 Absolute neutrophil count > 1,500/mm^3 Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 60 mL/min Bilirubin ≤ 2 times ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment No other malignancies except nonmelanomatous skin cancer Prior malignancies must be in remission for ≥ 5 years Patients with a known risk factor for human immunodeficiency virus (HIV) infection must undergo HIV testing within 90 days before study entry AND must be HIV negative by antibody detection, culture, or quantitative assay of plasma HIV ribonucleic acid (RNA) EXCLUSION CRITERIA: Presence of the following conditions within the past 6 months: Active infection Uncontrolled diabetes New York Heart Association class II-IV congestive heart failure Cerebrovascular accident Transient ischemic attack Uncontrolled hypertension Unstable angina Myocardial infarction History of rheumatic disorders, irritable bowel syndrome, or inflammatory bowel disease Known HIV positivity Known risk factors for HIV infection Prior radiotherapy or chemotherapy for this malignancy Prior pelvic radiotherapy Prior potentially curative surgery (i.e., abdominal or peritoneal resection) for anal cancer Pregnant or nursing
Sites / Locations
- Stanford Cancer Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Decatur Memorial Hospital Cancer Care Institute
- Kellogg Cancer Care Center
- Provena St. Mary's Regional Cancer Center - Kankakee
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates - Skokie
- CCOP - Carle Cancer Center
- Indiana University Melvin and Bren Simon Cancer Center
- William N. Wishard Memorial Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- Greater Baltimore Medical Center Cancer Center
- Hickman Cancer Center at Bixby Medical Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Lakeside Hospital
- Creighton University Medical Center
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Overlook Hospital
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- NYU Cancer Institute at New York University Medical Center
- Wood County Oncology Center
- Adena Regional Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Community Cancer Center
- Hematology Oncology Center
- Fairfield Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Southern Ohio Medical Center Cancer Center
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Fulton County Health Center
- Genesis - Good Samaritan Hospital
- Joan Karnell Cancer Center at Pennsylvania Hospital
- Fox Chase Cancer Center - Philadelphia
- Hematology and Oncology Associates of Northeastern Pennsylvania
- University of Virginia Cancer Center
- Fredericksburg Oncology, Incorporated
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- UW Cancer Center Johnson Creek
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- Marshfield Clinic - Lakeland Center
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Marshfield Clinic at Saint Michael's Hospital
- Marshfield Clinic - Wausau Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (closed to accrual as of 11/3/2008)
Arm II (open to accrual on 8/18/2009)
Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.