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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00527111
Other study ID # 05102
Secondary ID CA225269
Status Completed
Phase Phase 2
First received September 7, 2007
Last updated November 7, 2015
Start date February 2007
Est. completion date January 2015

Study information

Verified date November 2015
Source US Oncology Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Description:

Rectal cancer remains a significant cause of morbidity and mortality in the United States. Standard treatment for patients with locally advanced rectal cancer generally includes combined chemotherapy and radiotherapy administered either before (neoadjuvant) or after (adjuvant) definitive surgical resection. Published data from Germany has suggested advantages to a neoadjuvant strategy. Currently, the standard concurrent chemoradiotherapy regimen in the United States is pelvic irradiation administered concurrently with 5-fluorouracil (5-FU) given as a protracted venous infusion. However, local recurrence remains a problem. Recently completed randomized trials of chemoradiotherapy have demonstrated local recurrence rates between 8-17% even with currently accepted standard chemoradiotherapy and adequate surgical management.

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.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Cetuximab

5-fluorouracil

Radiation:
Pelvic irradiation


Locations

Country Name City State
United States New York Oncology Hematology, P.C. Albany New York
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 Raleigh Regional Cancer Center Beckley West Virginia
United States Highline Medical Oncology Burien Washington
United States Missouri Cance Associates Columbia Missouri
United States Methodist Charlton Cancer Ctr. Dallas Texas
United States Texas Cancer Center at Medical City 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 Willamette Valley Cancer Center Eugene Oregon
United States Texas Oncology, P.A. Fort Worth Texas
United States Central Indiana Cancer Centers Indianapolis Indiana
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Lake Vista Cancer Center Lewisville Texas
United States Longview Cance Center Longview Texas
United States Melbourne Internal Medicine Associates Melbourne Florida
United States Advanced Medical Specialties Miami Florida
United States Allison Cancer Center Midland Texas
United States Cancer Care & Hematology Specialists of Chicagoland, PC Niles Illinois
United States Virginia Oncology Associates Norfolk Virginia
United States Cancer Centers of Florida, P.A. Ocoee Florida
United States Texas Oncology-Odessa Odessa Texas
United States Kansas City Cancer Centers-Southwest Overland Park Kansas
United States Paris Regional Cancer Center Paris Texas
United States Cancer Centers of North Carolina Raleigh North Carolina
United States HOAST - Medical Dr. San Antonio Texas
United States Texas Cancer Center - Sherman Sherman Texas
United States Cancer Care Northwest-South Spokane Washington
United States St. Joseph Oncology, Inc. St. Joseph Missouri
United States Texas Oncology Cancer Center-Sugar Land Sugar Land Texas
United States Oncology Associates D.B.A. Hematology Oncology Physicians & Extenders Tucson Arizona
United States Tyler Cancer Center Tyler Texas
United States Northwest Cancer Specialists-Vancouver Vancouver Washington
United States Texas Oncology Cancer Care and Research Waco Texas
United States Texas Oncology, P.A. Webster Texas
United States Alliance Hematology Oncology PA Westminster Maryland
United States Texoma Cancer Center Wichita Falls Texas
United States Yakima Valley Mem Hosp/North Star Lodge Yakima Washington

Sponsors (3)

Lead Sponsor Collaborator
US Oncology Research Bristol-Myers Squibb, ImClone LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective of this study is to determine the pathologic response rate, using tumor regression grading, to treatment with preoperative chemoradiotherapy (pelvic radiotherapy with concurrent 5-FU) with and without concurrent ERBITUX. 7 weeks No
Secondary To determine response rate based on RECIST; the toxicity rates in patients who receive preoperative chemoradiotherapy with or without ERBITUX; local recurrence-free survival in these patient groups; overall and recurrence-free survival in these cohorts. 7 weeks No
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