Clinical trial NCT00574171 (phase 2, status: completed)
Conditions: metastatic colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: lapatinib, capecitabine
SMILES: CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Pathologically confirmed, locally advanced or metastatic adenocarcinoma of the colon
             or rectum

          -  Patients must have had progression of disease on prior therapy with an
             oxaliplatin-containing or irinotecan containing regimen

          -  Proper radiographic documentation of measurable disease using RECIST criteria

          -  ECOG performance status (PS) of 0 or 1

          -  Laboratory parameters:

        Hgb: ≥ 9.0 g/dl ANC ≥ 1500/ul Platelet ≥ 100,000/ul Creatinine ≤ 2x ULN OR Creatinine
        clearance ≥ 30 mg/ml Bilirubin ≤ 2x ULN AST ≤ 2x ULN or 5X ULN if liver metastases are
        present

          -  Patient has signed informed consent

          -  Toxicities from prior therapy (except alopecia and neuropathy) must have resolved to
             grade 1 or better prior to enrollment

        Exclusion Criteria:

          -  Administration of more than one prior systemic chemotherapy for metastatic disease

          -  Pregnant or breast-feeding women: female patients must agree to use effective
             contraception, must be surgically sterile, or must be postmenopausal. Male patients
             must agree to use effective contraception or be surgically sterile. The definition of
             effective contraception will be based on the judgment of the principal investigator or
             a designated associate. All at-risk female patients must have a negative serum
             pregnancy test within 7 days prior to randomization.

          -  Active inflammatory bowel disease, significant bowel obstruction, or chronic diarrhea
             (grade 2).

          -  Known human immunodeficiency virus (HIV) positivity or
             acquired-immunodeficiency-syndrome (AIDS)-related illness.

          -  No previous or concurrent malignancy is allowed except for adequately treated basal
             cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which
             the patient has been disease-free for 3 years.

          -  Known CNS metastases

          -  Prior therapy which specifically and directly targets the EGFR pathway

          -  Significant history of uncontrolled cardiovascular disease, defined as:

               -  History of uncontrolled or symptomatic angina

               -  History of arrhythmias requiring medications, or clinically significant, with the
                  exception of asymptomatic atrial fibrillation requiring anticoagulation

               -  Myocardial infarction < 6 months prior to study entry

               -  Cerebrovascular accident <6 months prior to study entry

               -  Uncontrolled or symptomatic congestive heart failure

               -  Ejection fraction below the institutional normal limit

               -  Any other cardiac condition, which in the opinion of the treating physician,
                  would make this protocol unreasonably hazardous for the patient