Clinical Research Details

A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer

The purpose of this study is to assess the pathologic complete response rate in participants with adenocarcinoma of the rectum, Stages II and III with wild-type K-ras treated with the combination of oxaliplatin, capecitabine and cetuximab given alone and given concomitantly with external beam radiation (EBRT), followed by surgery.

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Participant must have Stage II-III biopsy-proven (non-recurrent) primary adenocarcinoma of the rectum. The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by proctoscopic examination.

Tissue must be submitted for K-RAS analysis and participant must have been found to have wild-type k-ras mutation.

Participant must have measurable and/or non-measurable disease.

Clinical staging must include a CT scan of the chest, abdomen, and pelvis. Scans used for assessment of measurable disease must have been completed within 28 days prior to registration. Scans for assessment of non-measurable disease must have been performed within 42 days prior to registration.

Endoscopic ultrasonography is encouraged for accurate T stage.

Participant must not have received prior chemotherapy, radiation therapy or targeted therapy for this tumor.

Participant must not have received investigational agents for any reason within 28 days prior to registration.

Participant must not have had a prior severe reaction to a monoclonal antibody.

Participant must have recovered from any recent major surgeries (e.g., CABG, TURP, abdominal surgery).

Participant must be willing to have specimens submitted for K-RAS analysis.

Participant must have adequate blood counts and adequate liver function obtained within 28 days prior to registration:

You will receive a cycle of chemotherapy followed by a second cycle of chemotherapy and radiation therapy, followed by surgery.

Chemotherapy cycle 1 will last five weeks. During this time, you will receive oxaliplatin, cetuximab and capecitabine. You will take capecitabine by mouth twice a day, five days a week (Monday through Friday). You will be given oxaliplatin into your vein (IV) over a two-hour period once each week. You will be given cetuximab into your vein (IV) over a two-hour period once the first week, and then for a one-hour period once a week for weeks 2 through 5.

During weeks 6 and 7, you will not receive any chemotherapy.

Chemotherapy cycle 2 will start at week eight and last for five weeks. The chemotherapy will be the same as cycle 1. The only difference will be that you will not have oxaliplatin during the third week. During chemotherapy cycle 2, you will also have radiation treatments. For this, you will go to the radiation treatment area five times a week (Monday through Friday) for 5-6 weeks for about 45 minutes.

Between 3-8 weeks after your last radiation treatment, you will have surgery to try to remove any cancer that might remain.

Deepak Malhotra, M.D.

(708) 327-1240