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

NCT ID: NCT00725400

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-02-28

Brief Summary

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

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.

Conditions

Colorectal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients will receive a Cetuximab and Radiation Therapy.

Group Type: ACTIVE_COMPARATOR

Cetuximab and Radiation Therapy

Intervention Type: OTHER

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.

2

Patients will undergo Surgery before or after Radiation Therapy.

Group Type: ACTIVE_COMPARATOR

Surgery and Radiation Therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Other Intervention Names

Erbitux and Radiotherapy; Surgery and Radiotherapy

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

American Scitech International

OTHER

Sponsor Role: lead

Responsible Party

American Scitech International

Principal Investigators

Ratna Grewal, MD

Role: STUDY_CHAIR

American Scitech International- eCRO

Prem A Nandiwada, MD

Role: PRINCIPAL_INVESTIGATOR

Raritan Bay Medical Center

Sarat Babu, MD

Role: STUDY_DIRECTOR

St. Peter's Hospital

S N Agrawal, MD

Role: PRINCIPAL_INVESTIGATOR

JLR Hospital in India

Locations

Practicing Physician in New Jersey

Englishtown, New Jersey, United States

Countries

United States

Related Links

http://www.imclone.com

Related Info

http://www.bristolmyers.com

Related Info

Other Identifiers

JLRH-0000292008

Identifier Type: -

Identifier Source: secondary_id

IORG-0000392008

Identifier Type: -

Identifier Source: secondary_id

BMS-192008

Identifier Type: -

Identifier Source: secondary_id

IMCL-II-ASI-IORG-92008

Identifier Type: -

Identifier Source: secondary_id

ASI-CRCII0708

Identifier Type: -

Identifier Source: secondary_id

ASI-CRO0000192008

Identifier Type: -

Identifier Source: org_study_id