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
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- Objective tumor response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Bilirubin ≤ 1.5 mg/dL
- •Albumin ≥ 2.5 g/dL
- •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
- •No pulmonary embolism
- •No interstitial pneumonia
- •No extensive or symptomatic interstitial fibrosis of the lung
- •Neurologic:
- •No uncontrolled seizure disorder
- •No active neurological disease
- •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
Outcomes
Primary Outcomes
Objective tumor response rate
Time Frame: 4 year
Secondary Outcomes
- Tolerability(4 years)
- Progression free survival(4 years)
- Overall survival(4 Years)
- Quality of life(4 Years)