Clinical trial NCT00114231 (phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        -  Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2

          -  Patient must have histologically confirmed invasive adenocarcinoma of the rectum;
             Note: patients with rectal tumors suspicious for invasion also are eligible

          -  Distal border of the patient's tumor must be within 8 cm from the anal verge as
             measured on endoscopic exam

          -  Patients with tumors fixed to adjacent structures on digital exam are NOT eligible

          -  Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or
             endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4
             tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm

          -  Patients with positive perirectal nodes on ERUS examination are NOT eligible

          -  Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are
             NOT eligible

          -  Patients with the following conditions are NOT allowed on study:

               -  Metastatic disease or other primaries (patient must have had chest X-ray/computed
                  tomography [CT] and abdominal & pelvic CT/MRI with IV contrast, as well as a
                  colonoscopy)

               -  Previously documented history of familial adenomatous polyposis

               -  Previously documented history of hereditary non-polyposis colorectal cancer
                  diagnosed clinically (Amsterdam II criteria) or by genetic testing

               -  History of inflammatory bowel disease

               -  History of prior radiation treatments to pelvis

               -  Clinically significant peripheral sensory or motor neuropathy (defined as
                  symptomatic weakness, paresthesia or sensory alteration described to be
                  interfering with function, interfering with activities of daily living, disabling
                  or life-threatening)

               -  History of any clinically significant cardiac disease (i.e., class 3-4 congestive
                  heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia,
                  and/or myocardial infarction within the last 6 months)

               -  History of uncontrolled seizures or clinically significant central nervous system
                  disorders

               -  History of psychiatric conditions or diminished mental capacity that could
                  compromise the giving of informed consent, or interfere with study compliance

               -  History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin

               -  History of difficulty or inability to take or absorb oral medications

          -  White blood cells (WBC) >= 3000/mm^3

          -  Absolute neutrophil count (ANC) > 1,500/mm^3

          -  Hemoglobin > 9.5 mg/dl

          -  Platelet count >= 100,000/mm^3

          -  Total bilirubin =< 3 mg/dl

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0
             times institutional upper limit of normal (ULN)

          -  Alkaline phosphatase =< 2.0 times ULN

          -  Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation

          -  Patients who have experienced a prior malignancy must have received potentially
             curative therapy for that malignancy, and must be cancer-free for at least five years
             from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin
             carcinoma, or in-situ carcinomas)

          -  Patients of reproductive potential must agree to use an effective method of birth
             control when undergoing treatments with known or possible mutagenic or teratogenic
             effects; all female participants of childbearing potential must have a negative urine
             or serum pregnancy test within two weeks prior to study registration