Status:
WITHDRAWN
Study of Panitumumab Given First With Capecitabine and Oxaliplatin (CAPOX) and Then With Capecitabine and Radiation of the Pelvis for Treatment of Patients With Rectal Cancers That May or May Not Have Spread Beyond the Rectum
Lead Sponsor:
NSABP Foundation Inc
Collaborating Sponsors:
Amgen
Conditions:
Rectal Cancer
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Panitumumab is a monoclonal antibody. It works by attaching to a protein called epidermal growth factor receptor found on normal and cancer cells. When panitumumab attaches, it blocks another protein ...
Detailed Description
Colorectal cancers express EGF and/or EGFR mRNA in 66% of primary tumors, 44% of adjacent mucosa, and up to 62% of positive lymph nodes. Patients enrolled in NSABP FR-1 will begin therapy with the ant...
Eligibility Criteria
Inclusion
- Pathologic diagnosis of rectal cancer (adenocarcinoma)
- Must have rectal cancer that is:
- locally advanced and considered not to be curable by surgery
- recurrent (if it was treated before by surgical removal of the tumor)
- present along with small-volume metastasis
- Evidence of adequate organ function (such as liver, kidneys, etc.)
- Must be able to swallow tablets
- Able to perform an adequate level of physical activity
Exclusion
- Diagnosis of rectal cancer other than adenocarcinoma
- Patients who are candidates for surgical removal of metastatic and/or locally advanced disease
- Patients who have received previous treatments for the current cancer
- Chronic liver disease or recurrent viral hepatitis
- Any previous pelvic radiation therapy and/or any previous chemotherapy with oxaliplatin or epidermal growth factor receptor inhibitors
- Central nervous system metastases
- Active inflammatory bowel disease
- Current clinically significant abnormal peripheral nerve disease
- Active heart disease, including blocked blood vessels, recent heart attack, history of congestive heart failure, or abnormal heart beat
- Pregnancy or breast feeding
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00346099
Start Date
June 1 2006
End Date
May 1 2007
Last Update
January 7 2008
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