Clinical trial NCT00613080 (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, folfox
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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique
             that does not completely excise the lesion (e.g., fine needle aspiration, core needle
             biopsy)

               -  Located up to 12 cm from the anal verge with no extension of malignant disease
                  into the anal canal

               -  Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by
                  the following assessments:

                    -  Colonoscopy and biopsy within 56 days prior to registration

                    -  History/physical examination (including medication history screen for
                       contraindications) within 56 days prior to registration

                    -  Contrast-enhanced imaging of the abdomen and pelvis either by computed
                       tomography(CT), MRI, or Positron-emission tomography(PET)-CT (whole body
                       preferred) within 56 days prior to registration

                    -  Chest x-ray (or CT) of the chest within within 56 days prior to registration
                       to exclude distant metastases (except for patients who have had whole body
                       PET-CT)

                    -  Transrectal ultrasound (TRUS) within 56 days prior to registration required
                       to establish tumor stage

                         -  TRUS not required if clinical exam, CT of the pelvis, and/or MRI
                            demonstrates T4 lesion

          -  No synchronous primary colon carcinoma

          -  No evidence of distant metastases (M1)

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Zubrod performance status 0-2

          -  Absolute neutrophil count (ANC) ≥ 1,800/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0
             g/dL allowed)

          -  Aspartate aminotransferase (AST) < 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase < 2.5 times ULN

          -  Bilirubin ≤ 1.5 times ULN

          -  Creatinine clearance > 50 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a
             minimum of 3 years

        Exclusion criteria:

          -  Severe, active comorbidity, defined as follows:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the past 12 months

               -  Transmural myocardial infarction within the past 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy within the past 30 days

               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

               -  AIDS

               -  Evidence of uncontrolled seizures, central nervous system disorders, or
                  psychiatric disability judged by the investigator to be clinically significant,
                  precluding informed consent, or interfering with compliance of oral drug intake

               -  Known, existing uncontrolled coagulopathy, unless clinically stable on
                  anticoagulation therapy for ≥ 2 weeks

               -  Evidence of peripheral neuropathy ≥ grade 2

          -  Prior allergic reaction to oxaliplatin or capecitabine

          -  Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease
             that results in malabsorption; significant bowel resection that would make one
             concerned about the absorption of capecitabine) or malabsorption syndrome that would
             preclude feasibility of oral chemotherapy (i.e., capecitabine)

          -  Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided
             it was for a cancer other than colorectal cancer)

          -  Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiotherapy fields

          -  Major surgery within 28 days of study enrollment(other than diverting colostomy
             without tumor resection)

          -  Participation in any investigational drug study within 28 days of study enrollment.

          -  Concurrent cimetidine, amifostine, and/or depot Sandostatin