Clinical trial NCT00226941 (phase 1/phase 2, status: terminated)
Conditions: rectal cancer, colo-rectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cetuximab, oxaliplatin, capecitabine, diphenhydramine hydrochloride (hcl)
SMILES: [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O, [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, CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1
Reason stopped: 
    the response rate observed in the phase 1 portion of the study did not merit further evaluation
    in phase 2 portion of the study.
  
Eligibility criteria:

        INCLUSION CRITERIA

          -  Histologically-confirmed adenocarcinoma of the rectum. Clinical stages T3; T4; or N1
             as determined by endoscopic ultrasound; or a rectal CT or MRI scan are eligible,
             including T3 N0; T3 N1; T4 N0; T4 N1; T1-4 N1. Rectal cancers are defined as those
             whose distal border extends to within 12 cm of the anal verge.

          -  Age ≥ 18

          -  Karnofsky performance status (KPS) ≥ 70

          -  Leukocyte count > 3,500 x 10e6/µL

          -  Platelet count > 100,000/µL

          -  Serum glutamic-oxaloacetic transaminase (SGOT) < 2.5 x institutional upper limits of
             normal (ULN)

          -  Serum glutamic-pyruvic transaminase (SGPT) < 2.5 x ULN

          -  Alkaline phosphatase < 2.5 x ULN

          -  Total bilirubin < 1.5x ULN

          -  Creatinine:

               -  Within normal institutional limits

               -  OR

               -  Creatinine clearance > 60 mL/min/1.73 m2 (if serum creatinine levels above
                  institutional normal)

          -  Ability to swallow pills without difficulty

          -  Women of child-bearing potential must have a negative serum or urine pregnancy test
             (minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the
             start of study medication

          -  Women of child-bearing potential must be using an adequate method of contraception to
             avoid pregnancy throughout the treatment

        EXCLUSION CRITERIA

          -  Metastatic (M1) or stage IV disease

          -  Prior history of treatment with cetuximab or other therapy targeting EGFR

          -  Prior history of anti-cancer murine monoclonal antibody therapy

          -  Prior pelvic or whole abdominal radiotherapy

          -  Uncontrolled intercurrent illness including, but not limited to:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness / social situations that would limit compliance with study
                  requirements

          -  Patients with a concurrent malignancy or previous malignancy within 5 years of
             screening will be excluded from this study (EXCEPTION: concurrent or previous
             non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix
             may be allowed at the investigator's discretion)

          -  Inability to sign written consent

          -  Pregnant or breastfeeding

          -  Unwilling or unable to use effective contraception in self or partner for the entire
             study period and for up to 4 weeks after the study