Status:
TERMINATED
Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadj...
Detailed Description
The epidermal growth factor receptor (EGFR) present in normal and tumor cells is involved in signaling pathways affecting cellular growth, differentiation, proliferation and programmed cell death. Ove...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the rectum that begins within 15cm of the anal verge as determined by sigmoidoscopy and/or colonoscopy, with no evidence of distant metastatic disease. A complete colonoscopy to the cecum is recommended prior to initiating protocol therapy.
- Staging with transrectal ultrasound or endorectal coil Magnetic resonance imaging (MRI) to confirm clinical stage of T3 or T4 or lymph node positive rectal adenocarcinoma
- Tumor is K-ras wildtype by method of choice at respective institution (testing codons 12 and 13)
- Performance status: Eastern Cooperative Oncology Group Performance Score (ECOG PS) less than or equal to 2
- 18 years of age or older
- No evidence of metastatic disease by abdominal/pelvic (Computed tomography) CT and chest imaging
- Adequate bone marrow, renal,and hepatic function as outlined in protocol
- All patients will be evaluated by a surgeon and considered a candidate for definitive surgery
- Coumadin or heparin management for line care of other indications is permitted. The International Normalised Ratio (INR) will be monitored weekly in patients taking coumadin.
Exclusion
- Prior treatment for this malignancy
- Prior history of pelvic radiation therapy
- Prior history of 5-FU based or EGFR receptor inhibitor therapy
- Prior history of an allergic reaction to a monoclonal antibody
- Uncontrolled serious medical or psychiatric illness
- Significant history of uncontrolled cardiac disease
- Sexually active women of childbearing potential must use an effective method of birth control during the course of the study
- Unwilling to agree to pre and post-cetuximab sigmoidoscopy and biopsy
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00611858
Start Date
May 1 2008
End Date
September 1 2016
Last Update
January 8 2019
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
South Shore Hospital
Weymouth, Massachusetts, United States
4
Vanderbilt Medical Center
Nashville, Tennessee, United States