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

This study has been withdrawn prior to enrollment.
(Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.)
Sponsor:
Collaborators:
ImClone LLC
Bristol-Myers Squibb
Information provided by:
American Scitech International
ClinicalTrials.gov Identifier:
NCT00725400
First received: July 28, 2008
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Colorectal Carcinoma
Other: Cetuximab and Radiation Therapy
Procedure: Surgery and Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by American Scitech International:

Primary Outcome Measures:
  • Objective tumor response rate [ Time Frame: 4 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Surgery and Radiotherapy

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725400

Locations
United States, New Jersey
Practicing Physician in New Jersey
Englishtown, New Jersey, United States, 07726
Sponsors and Collaborators
American Scitech International
ImClone LLC
Bristol-Myers Squibb
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Ratna Grewal, American Scitech International
ClinicalTrials.gov Identifier: NCT00725400     History of Changes
Other Study ID Numbers: ASI-CRO0000192008, JLRH-0000292008, IORG-0000392008, BMS-192008, IMCL-II-ASI-IORG-92008, ASI-CRCII0708
Study First Received: July 28, 2008
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by American Scitech International:
Colorectal Cancer
Erbitux
Cetuximab
Surgery
Radiation

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014