Clinical trial NCT00107315 (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
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    terminated due to low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically* or cytologically* confirmed colorectal cancer

               -  Site of primary tumor must have been confirmed by endoscopy, radiography, or
                  surgery

               -  Metastatic disease NOTE: *Patients with a history of surgically treated
                  colorectal cancer who subsequently develop recurrent metastatic disease do not
                  require histologic or cytologic confirmation of metastatic disease unless an
                  interval of > 5 years has elapsed between initial primary surgery and the
                  development of metastases

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
                  OR ≥ 10 mm by spiral CT scan

          -  No known curative therapy exists

          -  No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or
             brain or CNS metastases)

        PATIENT CHARACTERISTICS:

        Age

          -  70 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

          -  Hemoglobin ≥ 9 g/dL

          -  No bleeding diathesis or coagulopathy

        Hepatic

          -  Bilirubin normal

          -  AST and ALT ≤ 3 times upper limit of normal (ULN)

          -  INR < 1.5 (unless on therapeutic anticoagulants)

          -  No unstable or uncompensated hepatic disease

        Renal

          -  Creatinine < 1.2 times ULN OR

          -  Creatinine clearance > 60 mL/min

          -  No unstable or uncompensated renal disease

        Cardiovascular

          -  No history of stroke

          -  No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)

          -  No myocardial infarction within the past year

          -  No New York Heart Association class II-IV congestive heart failure

          -  No unstable angina

          -  No serious cardiac dysrhythmia requiring medication

          -  No other clinically significant cardiovascular disease

          -  No other unstable or uncompensated cardiac disease

        Pulmonary

          -  No unstable or uncompensated respiratory disease

        Other

          -  Fertile patients must use effective contraception

          -  Able to receive oral medication

          -  No known hypersensitivity to fluorouracil or capecitabine

          -  No known dihydropyrimidine dehydrogenase deficiency

          -  No seizures not controlled by standard medical therapy

          -  No serious nonhealing wound, ulcer, or bone fracture

          -  No other malignancy within the past 5 years except completely excised nonmelanoma skin
             cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix

          -  No other severe or uncontrolled systemic disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior bevacizumab

        Chemotherapy

          -  Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment
             was administered > 6 months before the development of metastatic disease

          -  No prior chemotherapy for metastatic colon cancer

          -  No prior irinotecan or oxaliplatin

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  See Disease Characteristics

          -  More than 28 days since prior and no concurrent major surgery

          -  More than 28 days since prior open biopsy

          -  More than 7 days since prior fine needle aspiration or core biopsy

        Other

          -  More than 4 weeks since prior and no concurrent participation in another experimental
             drug study

          -  More than 30 days since prior non-approved or investigational drugs