Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed advanced, incurablecancers of the esophagus, liver, stomach, small bowel, pancreas, bile duct, colon orrectum and be eligible to receive chest, abdominal and/or pelvic radiation therapy (RT) for palliation; documentation of this is required in physician note;concomitant systemic therapy is not allowed during administration of palliative RT;palliative RT can be considered for advanced primary tumors or metastatic disease asabove

• Patients must not have received systemic chemotherapy for at least 4 weeks, and mustnot have received prior radiation therapy to the tumor site being irradiated on thisstudy

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

• Life expectancy of greater than 12 weeks

• Leukocytes >= 3,000/mcL

• Absolute neutrophil count >= 1,500/mcL

• Platelets >= 100,000/mcL

• Total bilirubin within normal institutional limits

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal

• Creatinine within normal institutional limits OR creatinine clearance >= 60mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry andfor the duration of study participation; should a woman become pregnant or suspectshe is pregnant while she or her partner is participating in this study, she shouldinform her treating physician immediately; men and women treated or enrolled on thisprotocol must also agree to use adequate contraception prior to the study, for theduration of study participation, and 4 months after completion of IPdRadministration

• Ability to understand and the willingness to sign a written informed consentdocument

• Human immunodeficiency virus (HIV) positive (+) patients with cluster ofdifferentiation 4 (CD4) counts >= 250 cells/mm^3 on anti-viral therapy

• Women of child-bearing potential must have a negative pregnancy test

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks fornitrosoureas or mitomycin C) prior to entering the study or those who have notrecovered from adverse events due to agents administered more than 4 weeks earlier

• Patients who are receiving any other investigational agents

• Patients with known brain metastases should be excluded from this clinical trial

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to IPdR

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements

• Pregnant women are excluded from this study; breastfeeding should be discontinued ifthe mother is treated with IPdR