Pre-op Rectal ChemoRad +/- Cetuximab

Completed · Phase 2

Conditions studied: Rectal Cancer

In brief

The purpose of this research study is to find out what effects (good and bad) cetuximab has on rectal cancer.

Key facts

Study ID

NCT00527111

Run by

US Oncology Research

People needed

139

Starts

2007-02-01

Expected to finish

2015-01-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Note: Please see Section 8.1 for the necessary "Prestudy Assessments".
• 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

You may not qualify if…

• A patient will be excluded from this study if s/he meets any of the following 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
• Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs. Patients, who have received prior radiotherapy to any regional site other than the pelvis, as long as all other inclusion criteria are met, could be considered for enrollment after discussion with Dr. McCollum.
• Is a pregnant or nursing woman
• Is unable to comply with requirements of study

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.