Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma
3 other identifiers
interventional
63
1 country
125
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work better by making tumor cells more sensitive to the drugs. It may also make tumor cells more sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin, fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of 11/3/2008) or stage III anal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2007
Longer than P75 for phase_2
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2006
CompletedFirst Posted
Study publicly available on registry
April 21, 2006
CompletedStudy Start
First participant enrolled
February 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedResults Posted
Study results publicly available
August 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2021
CompletedJune 29, 2023
June 1, 2023
8.7 years
April 19, 2006
July 18, 2016
June 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local Failure Rate at 3 Years
Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it.
assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
Secondary Outcomes (4)
3-year Overall Survival Rate
assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
3-year Progression-free Survival Rate
assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
Objective Response Rate
Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST
3-year Colostomy-free Survival Rate
assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3
Study Arms (2)
Arm I (closed to accrual as of 11/3/2008)
EXPERIMENTALPatients 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.
Arm II (open to accrual on 8/18/2009)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Given IV
Given once daily 5 days a week for 5 weeks
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (125)
Stanford Cancer Center
Stanford, California, 94305-5824, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Kellogg Cancer Care Center
Highland Park, Illinois, 60035, United States
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, 60901, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, 60714, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, 70112, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, 21204, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, 55125, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131-2197, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, 45662, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, 18510, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (1)
Garg M, Lee JY, Kachnic LA, et al.: Phase II trials of cetuximab (CX) plus cisplatin (CDDP), 5-fluorouracil (5-FU) and radiation (RT) in immunocompetent (ECOG 3205) and HIV-positive (AMC045) patients with squamous cell carcinoma of the anal canal (SCAC): safety and preliminary efficacy results. [Abstract] J Clin Oncol 30 (Suppl 15): A-4030, 2012.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- ECOG-ACRIN statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- STUDY CHAIR
Madhur K. Garg, MD
Montefiore Medical Center
- STUDY CHAIR
Joseph A. Sparano, MD
Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2006
First Posted
April 21, 2006
Study Start
February 28, 2007
Primary Completion
November 1, 2015
Study Completion
August 17, 2021
Last Updated
June 29, 2023
Results First Posted
August 29, 2016
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.