Status:
WITHDRAWN
Comparative Study of Cetuximab and Radiation Vs Surgery Before or After Radiation in Patients With Colorectal Carcinoma
Lead Sponsor:
American Scitech International
Collaborating Sponsors:
Eli Lilly and Company
Bristol-Myers Squibb
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 wh...
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 det...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00725400
Start Date
February 1 2010
End Date
February 1 2014
Last Update
July 20 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Practicing Physician in New Jersey
Englishtown, New Jersey, United States, 07726