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

NCT00725400 | Withdrawn Phase 2

• 6 other identifiers: ASI-CRO0000192008JLRH-0000292008IORG-0000392008BMS-192008IMCL-II-ASI-IORG-92008ASI-CRCII0708
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Carcinoma

Keywords

Colorectal Cancer; Erbitux; Cetuximab; Surgery; Radiation

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate

  4 year

Secondary Outcomes (4)

• Tolerability

  4 years

• Progression free survival

  4 years

• Overall survival

  4 Years

• Quality of life

  4 Years

Study Arms (2)

1

ACTIVE COMPARATOR

Patients will receive a Cetuximab and Radiation Therapy.

Other: Cetuximab and Radiation Therapy

2

ACTIVE COMPARATOR

Patients will undergo Surgery before or after Radiation Therapy.

Procedure: Surgery and Radiation Therapy

Interventions

Cetuximab and Radiation Therapy 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.

Also known as: Erbitux and Radiotherapy

1

Surgery and Radiation Therapy 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.

Also known as: Surgery and Radiotherapy

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• American Scitech International: lead
• Eli Lilly and Company: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Practicing Physician in New Jersey

Englishtown, New Jersey, 07726, United States

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Ratna Grewal, MD

  American Scitech International- eCRO

  STUDY CHAIR

• Prem A Nandiwada, MD

  Raritan Bay Medical Center

  PRINCIPAL INVESTIGATOR

• Sarat Babu, MD

  St. Peter's Hospital

  STUDY DIRECTOR

• S N Agrawal, MD

  JLR Hospital in India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: February 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (1)