Pre-op Rectal ChemoRad +/- Cetuximab

NCT00527111 | Completed Phase 2 Results

• 2 other identifiers: 05102CA225269
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 41

Brief Summary

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

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.

  A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.

  5 years

Secondary Outcomes (4)

• To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.

  5 years

• 5- Year Overall Survival (OS) Rate

  5 years

• Recurrence-free Survival (RFS) Rate at 5 Years

  5 years

• KRAS Mutation Rate

  5 years

Study Arms (2)

Chemoradiotherapy plus Cetuximab

EXPERIMENTAL

Pelvic irradiation plus 5-fluorouracil plus cetuximab

Drug: Cetuximab; Drug: 5-fluorouracil; Radiation: Pelvic irradiation

Chemoradiotherapy alone

ACTIVE COMPARATOR

Pelvic irradiation plus 5-fluorouracil

Drug: 5-fluorouracil; Radiation: Pelvic irradiation

Interventions

Cetuximab DRUG

Also known as: Erbitux

Chemoradiotherapy plus Cetuximab

5-fluorouracil DRUG

Also known as: 5-FU

Chemoradiotherapy alone; Chemoradiotherapy plus Cetuximab

Pelvic irradiation RADIATION

Also known as: Radiotherapy

Chemoradiotherapy alone; Chemoradiotherapy plus Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Note: Please see Section 8.1 for the necessary "Prestudy Assessments".
• 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
• Is a pregnant or nursing woman
• Is unable to comply with requirements of study

Sponsors & Collaborators

• US Oncology Research: lead
• Bristol-Myers Squibb: collaborator
• Eli Lilly and Company: collaborator

Study Sites (41)

Oncology Associates D.B.A. Hematology Oncology Physicians & Extenders

Tucson, Arizona, 85704, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Advanced Medical Specialties

Miami, Florida, 33133, United States

Location

Cancer Centers of Florida, P.A.

Ocoee, Florida, 34761, United States

Location

Cancer Care & Hematology Specialists of Chicagoland, PC

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 76227, United States

Location

Kansas City Cancer Centers-Southwest

Overland Park, Kansas, 66210, United States

Location

Alliance Hematology Oncology PA

Westminster, Maryland, 21157, United States

Location

Missouri Cance Associates

Columbia, Missouri, 65201, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Texas Oncology - Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Oncology Cance Center

Austin, Texas, 78731, United States

Location

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Methodist Charlton Cancer Ctr.

Dallas, Texas, 75237, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Texas Cancer Center

Denton, Texas, 76210, United States

Location

El Paso Cancer Treatment Ctr

El Paso, Texas, 79915, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

Lake Vista Cancer Center

Lewisville, Texas, 75067, United States

Location

Longview Cance Center

Longview, Texas, 75601, United States

Location

Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology-Odessa

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, United States

Location

HOAST - Medical Dr.

San Antonio, Texas, 78229, United States

Location

Texas Cancer Center - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology Cancer Center-Sugar Land

Sugar Land, Texas, 77479, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology Cancer Care and Research

Waco, Texas, 76712, United States

Location

Texas Oncology, P.A.

Webster, Texas, 77598, United States

Location

Texoma Cancer Center

Wichita Falls, Texas, 76310, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Highline Medical Oncology

Burien, Washington, 98166, United States

Location

Cancer Care Northwest-South

Spokane, Washington, 99202, United States

Location

Northwest Cancer Specialists-Vancouver

Vancouver, Washington, 98684, United States

Location

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, 98902, United States

Location

Raleigh Regional Cancer Center

Beckley, West Virginia, 25801, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Cetuximab; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Results Point of Contact

• Title: Dr. David McCollum
• Organization: US Oncology Network, McKesson Specialty Health

david.mccollum@usoncology.com

214-370-1080

Study Officials

• Andrew D McCollum, MD

  US Oncology Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 3, 2016
• Results First Posted: November 3, 2016

Record last verified: 2016-09

Locations

US (41)