Clinical trial NCT00081224 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, celecoxib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed rectal adenocarcinoma

               -  Clinical stage T3, N0, M0 OR any T, N1-3, M0 disease

          -  Treatment with neoadjuvant chemotherapy and pelvic radiotherapy is indicated

               -  All disease must be encompassable within standard pelvic radiotherapy fields

          -  Distal border of the tumor must be at or below* the peritoneal reflection, defined as
             within 12 cm of the anal verge by endoscopy NOTE: *If a portion of the tumor is below
             the peritoneal reflection at the time of surgery, patients are eligible regardless of
             the distance of the tumor determined at endoscopy

          -  Tumor must be determined to be clinically resectable

               -  Tumor may not be clinically fixed

               -  Negative margins by routine examination of an unanesthetized patient

          -  Transmural penetration of tumor through the muscularis propria by CT scan, endorectal
             ultrasound, or MRI

          -  No distant metastatic disease

               -  No evidence of tumor outside the pelvis, including any of the following:

                    -  Metastatic inguinal lymphadenopathy

                    -  Peritoneal seeding

                    -  Liver metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  At least 6 months

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ upper limit of normal (ULN)

          -  AST ≤ 3 times ULN

          -  Alkaline phosphatase ≤ 4 times ULN if AST < ULN

        Renal

          -  Creatinine clearance ≥ 30 mL/min

          -  No renal impairment

        Cardiovascular

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No uncontrolled cardiac arrhythmias

          -  No myocardial infarction

          -  No history of transient ischemic attacks or stroke

          -  No other clinically significant cardiac disease

        Gastrointestinal

          -  No bleeding peptic ulcer disease within the past 12 months

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No malabsorption syndrome

          -  No active inflammatory bowel disease

          -  Must be able to swallow study drugs

        Other

          -  No dihydropyrimidine dehydrogenase deficiency

          -  No history of uncontrolled seizures

          -  No CNS disorders

          -  No clinically significant psychiatric illness that would preclude study compliance or
             giving informed consent

          -  No other malignancy within the past 5 years except basal cell or squamous cell skin
             cancer or carcinoma in situ of the cervix

          -  No known sensitivity to NSAIDs, sulfonamides, or aspirin

          -  No other serious medical illness that would preclude study treatment

          -  No other conditions that would preclude study participation

          -  Must be able to tolerate major surgery that may include abdominal-perineal resection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 30 days after study
             treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  No prior systemic anticancer chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  No prior radiotherapy to the pelvis

        Surgery

          -  See Disease Characteristics

          -  More than 3 weeks since prior major surgery and recovered

        Other

          -  At least 7 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including
             aspirin

          -  No other concurrent investigational drugs

          -  No other concurrent anticancer treatment

          -  No concurrent NSAIDs

          -  No concurrent primary prophylactic therapy for hand-foot syndrome

          -  No concurrent loperamide prophylaxis for diarrhea

          -  No concurrent sorivudine or brivudine