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A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

7 weeks

Safety Issue:

No

Principal Investigator

Andrew D McCollum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research

Authority:

United States: Institutional Review Board

Study ID:

CA225269

NCT ID:

NCT00527111

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Tyler Cancer CenterTyler, Texas  75702
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
New York Oncology Hematology, P.C.Albany, New York  12208
Cancer Centers of Florida, P.A.Orlando, Florida  
Northwest Cancer Specialists-VancouverVancouver, Washington  98684
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
Texoma Cancer CenterWichita Falls, Texas  76310
Highline Medical OncologyBurien, Washington  98166
Texas Cancer CenterAbilene, Texas  79606
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
Lake Vista Cancer CenterLewisville, Texas  75067
Paris Regional Cancer CenterParis, Texas  75460
Texas Cancer Center - ShermanSherman, Texas  75090-0504
Melbourne Internal Medicine AssociatesMelbourne, Florida  32901
El Paso Cancer Treatment CtrEl Paso, Texas  79915
Texas Oncology Cancer Center-Sugar LandSugar Land, Texas  77479
Cancer Care Northwest-SouthSpokane, Washington  99202
Yakima Valley Mem Hosp/North Star LodgeYakima, Washington  98902
Kansas City Cancer Centers-SouthwestOverland Park, Kansas  66210
HOAST - Medical Dr.San Antonio, Texas  78229
Alliance Hematology Oncology PAWestminster, Maryland  21157
Advanced Medical SpecialtiesMiami, Florida  33176
Cancer Care & Hematology Specialists of Chicagoland, PCNiles, Illinois  60714
Cancer Centers of North CarolinaRaleigh, North Carolina  27607
Texas Oncology - AmarilloAmarillo, Texas  79106
Methodist Charlton Cancer Ctr.Dallas, Texas  75237
Texas Oncology-OdessaOdessa, Texas  79761
Texas Oncology Cancer Care and ResearchWaco, Texas  76712
Raleigh Regional Cancer CenterBeckley, West Virginia  25801
Oncology Associates D.B.A. Hematology Oncology Physicians & ExtendersTucson, Arizona  85704
Missouri Cance AssociatesColumbia, Missouri  65201
Texas Oncology Cance CenterAustin, Texas  78731
Longview Cance CenterLongview, Texas  75601