Clinical trial NCT00084591 (phase 1, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary adenocarcinoma of the rectum

               -  Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam

               -  Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:

                    -  Physical exam

                    -  Transrectal ultrasound

                    -  Pelvic CT scan

                    -  Pelvic MRI

          -  No clinical evidence of metastatic disease

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  No known, uncontrolled coagulopathy

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  SGOT and SGPT ≤ 1.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times normal

          -  Creatinine clearance > 50 mL/min

        Cardiovascular

          -  No clinically significant cardiac disease

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No poorly controlled cardiac arrhythmias

          -  No myocardial infarction within the past year

        Gastrointestinal

          -  No active inflammatory bowel disease

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No malabsorption syndrome

        Other

          -  No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the
             cervix or non-melanoma skin cancer

          -  No concurrent serious, uncontrolled infection(s)

          -  No prior unanticipated severe reaction to fluoropyrimidine therapy

          -  No known sensitivity to fluorouracil

          -  No prior uncontrolled seizures

          -  No CNS disorders that would preclude study participation

          -  No other medical or psychiatric condition that would preclude study participation

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior immunotherapy for rectal cancer

        Chemotherapy

          -  No prior chemotherapy for rectal cancer

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy for rectal cancer

          -  No prior pelvic radiotherapy

        Surgery

          -  More than 4 weeks since prior major surgery and recovered

          -  No prior surgery for rectal cancer

        Other

          -  More than 4 weeks since prior participation in another investigational drug study

          -  No concurrent celecoxib