A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer

Inclusion Criteria: * Primary rectal cancer * Planned course of conventional neoadjuvant radiation therapy before surgery * Scheduled to receive chemotherapy * \>/= 18 years of age * Negative pregnancy test Exclusion Criteria: * History of acute or chronic regional enteritis or inflammatory bowel disease * Stool incontinence * Uncontrollable diarrhea * Abdominal-perineal resection or other surgery leaving patient without a functioning rectum * Patients using colostomy or ileostomy * Liver function tests \> 3x upper limit of normal, or bilirubin test result \> 1.5 the upper limit of normal * Calculated creatinine clearance \<60 mL/minute * Planned hyperfractionated or split course radiation * Planned brachytherapy prior to completion of all external beam radiation therapy * Prior pelvic RT * An on-going infection * ECOG score \>/= 3 * Leukopenia \<2,000 WBC/mm3 or Hg \<10.5 g/dL * Participation in an investigational drug trial within the previous 30 days * Patients with a medical condition that would interfere with study compliance * Known hypersensitivity to 5-FU or capecitabine * Anticipated inability to tolerate oral administration of SGX201 * Pregnant or breastfeeding