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

• Status: Withdrawn
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 called epidermal growth factor (EGF) from attaching to the cell. This is important because, when EGF is blocked, a cell's growth slows down or stops. Panitumumab may also help radiation therapy work. Also because panitumumab is a fully-human antibody, it may be less toxic than other monoclonal antibodies made to block the EGF receptor. Chemotherapy, such as capecitabine and oxaliplatin, works to kill cancer cells directly. Capecitabine given during radiation helps radiation therapy work better. This study is being done to learn how rectal cancer tumors that are not removed surgically respond to treatment with panitumumab and chemotherapy given before radiation therapy begins followed by treatment with panitumumab and capecitabine given with radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NSABP Foundation Inc
• Collaborator: Amgen
• Treatments: Antibodies, Monoclonal; Capecitabine; Oxaliplatin; Panitumumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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