Comparative Study of Cetuximab and Radiation Vs Surgery Before or After Radiation in Patients With Colorectal Carcinoma

July 19, 2011 updated by: American Scitech International

Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma

RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.This is an anti-cancer drug which has already been approved by the FDA for use in patients who have Colorectal Cancer. Cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation Therapy uses high-energy x-rays to kill tumor cells and cause less damage to normal tissue . Giving the drug Cetuximab together with Radiation Therapy may kill more tumor cells. Surgery is the most common treatment for Colorectal Cancer to remove the tumor, as well as a small margin of surrounding normal tissue and possibly nearby lymph nodes. Surgery is usually used in conjunction with other conventional treatments such as Radiation Therapy. Radiation Therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation Therapy after surgery may kill any tumor cells that remain after surgery.

Screening test such as Fecal Occult Blood Test (FOBT) and Colonoscopy has to be done. Tumor markers for Colorectal Carcinoma are Carcinoembryonic antigen (CAE) and CA 19-9 and to assess the response of tumor markers Carcinoembryonic antigen (CAE) and CA 19-9 will be used and periodically Colonoscopy has to be done. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation.

PURPOSE: Determine the tumor response rate treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy in patients with Colorectal Cancer from stage II to IV

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary:

  • Determine the response rate in patients with Colorectal Cancer treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy.

Secondary:

  • To determine the progression-free survival and overall survival of patients treated with these regimens.
  • Compare the treatment compliance of patients treated with these regimens.
  • Compare the safety of these regimens in these patients.

OUTLINE: This is an Open-label, Controlled, Multicenter study. Patients will be assigned into two different Arms.

Arm I: Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.

Arm II: Patients will undergo surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.

PROJECTED ACCRUAL: Approximately 450 patients will be accrued for this study within 18 to 24 months.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Englishtown, New Jersey, United States, 07726
        • Practicing physician in New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with stage II- IV Colorectal Cancer
  • Patients must be 40 years and older
  • Patients may be of any race and either gender
  • Signed Informed Consent

Patient characteristics:

  • Age: 40 years and older
  • Sex: Both
  • Performance status: Not specified
  • Life expectancy: Not specified

Hematopoietic:

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • No history of significant bleeding events within the past 6 months

Hepatic:

  • Bilirubin ≤ 1.5 mg/dL
  • Albumin ≥ 2.5 g/dL

Renal:

  • Creatinine ≤ 1.5 times upper limit of normal
  • Protein < 1+ by urinalysis
  • Protein < 1 g by 24-hour urine collection

Cardiovascular:

  • No conduction defect in heart
  • No congestive heart failure
  • No myocardial infarction within last 6 months
  • No cerebrovascular accident
  • No uncontrolled hypertension
  • No clinically significant peripheral artery disease

Pulmonary:

  • No pulmonary embolism
  • No interstitial pneumonia
  • No extensive or symptomatic interstitial fibrosis of the lung

Neurologic:

  • No uncontrolled seizure disorder
  • No active neurological disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test

Exclusion Criteria:

  • Age below 40 years
  • Brain or nervous system metastases
  • Any current mental illness
  • Hemoglobin is less than 9.0 g/dl
  • CBC results are below normal range
  • Patients with Hepatitis B or C or who are HIV positive
  • Pregnant or nursing patients are not eligible for entry into the study
  • Hepatic abnormality AST/ALT > 4 folds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients will receive a Cetuximab and Radiation Therapy.
Other: Cetuximab and Radiation Therapy
Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
Other Names:
  • Erbitux and Radiotherapy
Active Comparator: 2
Patients will undergo Surgery before or after Radiation Therapy.
Procedure: Surgery and Radiation Therapy
Patients will undergo Surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
Other Names:
  • Surgery and Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective tumor response rate
Time Frame: 4 year
4 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 4 years
4 years
Tolerability
Time Frame: 4 years
4 years
Overall survival
Time Frame: 4 Years
4 Years
Quality of life
Time Frame: 4 Years
4 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Scitech International

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company

Investigators

  • Study Chair: Ratna Grewal, MD, American Scitech International- eCRO
  • Principal Investigator: Prem A Nandiwada, MD, Raritan Bay Medical Center
  • Study Director: Sarat Babu, MD, St. Peter's Hospital
  • Principal Investigator: S N Agrawal, MD, JLR Hospital in India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-CRO0000192008
  • JLRH-0000292008
  • IORG-0000392008
  • BMS-192008
  • IMCL-II-ASI-IORG-92008
  • ASI-CRCII0708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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