Clinical trial NCT00070434 (phase 2, status: withdrawn)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin, pyridoxine
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, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CC1=C(O)C(CO)=C(CO)C=N1
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary adenocarcinoma of the rectum

          -  Locally advanced disease (clinical T3-4, N0-2, M0) based on at least 1 of the
             following criteria:

               -  Clinically fixed tumors on rectal examination with tumor adherent to the pelvic
                  sidewall and/or sacrum

               -  Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack
                  of clear tissue plane is considered evidence of fixation

               -  Hydronephrosis on CT scan or intravenous pyelogram of ureteric or bladder
                  invasion by cystoscopy and cytology or biopsy

               -  Invasion into the prostate, vagina, or uterus

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

          -  Distal border of the tumor must be at or below the peritoneal reflection (within 12 cm
             of the anal verge) by proctoscopic examination

          -  Measurable disease by x-ray, scans, or physical examination

          -  Available tumor tissue to determine molecular profile of the tumor before study
             treatment

          -  No clinical evidence of high-grade (lumen diameter < 1 cm) large bowel obstruction
             unless a diverting colostomy has been performed

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC ≥ 3,500/mm^3

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

          -  Platelet count ≥100,000/mm^3

        Hepatic

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

          -  SGOT or SGPT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

        Renal

          -  See Disease Characteristics

          -  Creatinine ≤ 1.5 times ULN OR

          -  Estimated creatinine clearance > 50 mL/min

        Cardiovascular

          -  No significant cardiac disease

          -  No recent myocardial infarction

        Gastrointestinal

          -  See Disease Characteristics

          -  Able to swallow oral medication

          -  No active inflammatory bowel disease

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

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

          -  No prior unanticipated severe reaction to study drugs

          -  No known dihydropyrimidine dehydrogenase deficiency

          -  No serious uncontrolled infection

          -  No other serious medical illness that would preclude study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for colon or rectal cancer

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior pelvic radiotherapy

          -  No prior intra-operative radiotherapy or brachytherapy

          -  No concurrent intra-operative radiotherapy or brachytherapy

          -  No concurrent intensity-modulated radiotherapy

        Surgery

          -  See Disease Characteristics

          -  See Radiotherapy