Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2007-02-28
2015-01-31
Brief Summary
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Detailed Description
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Several recent trials have explored the use of radiotherapy and cetuximab with good results.
Because of the non-overlapping toxicity profiles and the potentially diverse and complimentary mechanisms of action, the combination of chemotherapy plus ERBITUX given concurrently with pelvic radiotherapy may improve on the outcomes seen with current standards for patients with locally advanced adenocarcinoma of the rectum.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemoradiotherapy plus Cetuximab
Pelvic irradiation plus 5-fluorouracil plus cetuximab
Cetuximab
5-fluorouracil
Pelvic irradiation
Chemoradiotherapy alone
Pelvic irradiation plus 5-fluorouracil
5-fluorouracil
Pelvic irradiation
Interventions
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Cetuximab
5-fluorouracil
Pelvic irradiation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
A patient will be eligible for inclusion in this study if s/he meets all of the following criteria:
* Has a histologically confirmed diagnosis of newly diagnosed adenocarcinoma of the rectum (tumor within 15 cm of the anal verge). Location of tumor (lower 1/3rd vs. middle or upper 1/3rd) and pre-treatment nodal status (N0 vs. N1 or N2) will be recorded in the eCRF. Patients with only non-measurable disease are eligible as long as they meet the other disease requirements in this criterion as well as all other eligibility criteria.
* Has tumor that is locally advanced (T3/T4 or lymph node positive) by preoperative assessment with CT or MRI imaging or transrectal ultrasonography.
* Has no evidence of distant metastases by radiographic staging
* Has an ECOG Performance Status (PS) 0-1
* Is greater than 18 years of age
* Has adequate marrow and organ system function as assessed by the following lab values:
White blood cell (WBC) count See protocol for specific details Absolute neutrophil count (ANC) See protocol for specific details Hemoglobin See protocol for specific details Total bilirubin See protocol for specific details AST and ALT See protocol for specific details Serum creatinine See protocol for specific details Platelet count See protocol for specific details
* Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.
Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
All WOCBP MUST have a negative pregnancy test within 3 weeks prior to registration (confirmed within 7 days prior to first receiving investigational product). If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (eg, missed or late menstrual period) at any time during study participation.
The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study.
* Has signed a Patient Informed Consent Form
* Has signed a Patient Authorization Form
* Is a pregnant or nursing woman
* Is unable to comply with requirements of study
Exclusion Criteria
* Has another disease similar to one being studied (ie, colon cancer)
* Has evidence of distant metastases by radiographic staging
* Has had prior treatment for the current disease
* Has had prior stem cell or bone marrow transplant or any organ transplant with the exception of corneal transplant or cadaver bone graft
* Has a history of hypersensitivity to any of study treatments
* Has had a prior severe infusion reaction to a monoclonal antibody
* Has received prior therapy, at any time, which specifically and directly targets the EGFR pathway
* Has a significant history of uncontrolled cardiac disease; ie, uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction
* Has evidence of CNS involvement (CNS imaging is not required for study enrollment unless clinically suspected CNS disease is present.)
* Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or Gilbert's Syndrome
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Eli Lilly and Company
INDUSTRY
US Oncology Research
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew D McCollum, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Research
Locations
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Oncology Associates D.B.A. Hematology Oncology Physicians & Extenders
Tucson, Arizona, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, United States
Advanced Medical Specialties
Miami, Florida, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
Cancer Care & Hematology Specialists of Chicagoland, PC
Niles, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
Alliance Hematology Oncology PA
Westminster, Maryland, United States
Missouri Cance Associates
Columbia, Missouri, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Texas Oncology - Amarillo
Amarillo, Texas, United States
Texas Oncology Cance Center
Austin, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Cancer Center
Denton, Texas, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
Lake Vista Cancer Center
Lewisville, Texas, United States
Longview Cance Center
Longview, Texas, United States
Allison Cancer Center
Midland, Texas, United States
Texas Oncology-Odessa
Odessa, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
HOAST - Medical Dr.
San Antonio, Texas, United States
Texas Cancer Center - Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care and Research
Waco, Texas, United States
Texas Oncology, P.A.
Webster, Texas, United States
Texoma Cancer Center
Wichita Falls, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Highline Medical Oncology
Burien, Washington, United States
Cancer Care Northwest-South
Spokane, Washington, United States
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States
Raleigh Regional Cancer Center
Beckley, West Virginia, United States
Countries
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Other Identifiers
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CA225269
Identifier Type: OTHER
Identifier Source: secondary_id
05102
Identifier Type: -
Identifier Source: org_study_id