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Rectal CancerPhase 2NCT00527111

Pre-op Rectal ChemoRad +/- Cetuximab

A Phase 2 study testing Cetuximab, 5-fluorouracil and Pelvic irradiation in people with Rectal Cancer, run by US Oncology Research at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Cetuximab, 5-fluorouracil and Pelvic irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
41 sitesUnited States
Study dates
Feb 2007to Jan 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Texas Oncology Cance Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Raleigh Regional Cancer Center

    Beckley, West Virginia, 25801

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Missouri Cance Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Methodist Charlton Cancer Ctr.

    Dallas, Texas, 75237

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Cancer Center

    Denton, Texas, 76210

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 76227

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Longview Cance Center

    Longview, Texas, 75601

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Advanced Medical Specialties

    Miami, Florida, 33133

  • Allison Cancer Center

    Midland, Texas, 79701

  • Cancer Care & Hematology Specialists of Chicagoland, PC

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • Texas Oncology-Odessa

    Odessa, Texas, 79761

  • Kansas City Cancer Centers-Southwest

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • HOAST - Medical Dr.

    San Antonio, Texas, 78229

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest-South

    Spokane, Washington, 99202

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

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

    Tucson, Arizona, 85704

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care and Research

    Waco, Texas, 76712

  • Texas Oncology, P.A.

    Webster, Texas, 77598

  • Alliance Hematology Oncology PA

    Westminster, Maryland, 21157

  • Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

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

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

Read the detailed 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.

Conditions
Rectal Cancer
Being tested
Cetuximab, 5-fluorouracil, Pelvic irradiation
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabDrug

    Also called Erbitux

  • 5-fluorouracilDrug

    Also called 5-FU

  • Pelvic irradiationRadiation

    Also called Radiotherapy

Study groups in NCT00527111
Study groupRoleWhat they receive
Chemoradiotherapy plus CetuximabExperimentalPelvic irradiation plus 5-fluorouracil plus cetuximab
Receives: Drug: Cetuximab; Drug: 5-fluorouracil; Radiation: Pelvic irradiation
Chemoradiotherapy aloneActive comparatorPelvic irradiation plus 5-fluorouracil
Receives: Drug: 5-fluorouracil; Radiation: Pelvic irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (4)

  1. 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.

    Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    Measured: 5 years

  2. 5- Year Overall Survival (OS) Rate

    Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.

    Measured: 5 years

  3. Recurrence-free Survival (RFS) Rate at 5 Years

    RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact.

    Measured: 5 years

  4. KRAS Mutation Rate

    Percentage of Participants with KRAS mutation.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527111
Sponsor's protocol ID
05102
Other IDs
CA225269
Status last verified
Sep 2016
First submitted
7 Sep 2007
Last updated
3 Nov 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, 5-fluorouracil and Pelvic irradiation in people with Rectal Cancer, run by US Oncology Research at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.

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Pre-op Rectal ChemoRad +/- Cetuximab (NCT00527111) | AzTrials