Clinical trial NCT00290615 (phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, oxaliplatin
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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the colon or rectum

               -  Unresectable disease

               -  Metastatic or recurrent disease

          -  Not amenable to potentially curative treatment

          -  No untreated leptomeningeal or brain metastases

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 2,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  No known uncontrolled coagulopathy

        Hepatic

          -  AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if liver metastases
             are present)

          -  Bilirubin < 2.0 times ULN

        Renal

          -  Creatinine clearance > 40 mL/min

          -  Urine protein negative

          -  Urine protein:creatinine ratio > 1

        Cardiovascular

          -  No unstable or uncontrolled hypertension (i.e., blood pressure [BP] > 150/100 mm Hg
             despite antihypertensive therapy)

               -  Patients who recently started or have adjusted antihypertensive medications are
                  eligible provided BP is < 140/90 mm Hg for ≥ 3 different measurements over 14
                  days

          -  No arterial thromboembolic events within the past 6 months, including any of the
             following:

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Unstable angina

               -  Myocardial infarction

               -  Clinically significant peripheral vascular disease

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

          -  No uncontrolled symptomatic coronary artery disease or cardiac arrhythmia

          -  No other significant uncontrolled cardiac disease

        Gastrointestinal

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No malabsorption syndrome

          -  No inability to tolerate oral medication

        Immunologic

          -  No prior severe infusion reaction to a monoclonal antibody

          -  No history of an allergic reaction attributed to compounds of similar chemical or
             biologic composition to oxaliplatin, cetuximab, capecitabine, or bevacizumab

          -  No prior unanticipated, severe reaction to fluoropyrimidine therapy or known
             hypersensitivity to fluoroucacil

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during the study and for 3-4 months
             after completion of study treatment

          -  No peripheral neuropathy ≥ grade 2

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

          -  No known dihydropyrimidine dehydrogenase deficiency

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior adjuvant bevacizumab or cetuximab

          -  No other concurrent anticancer immunotherapy or biologic therapy

        Chemotherapy

          -  At least 6 months since a prior adjuvant fluorouracil-, leucovorin calcium-, or
             capecitabine-based regimen

          -  At least 12 months since prior adjuvant oxaliplatin

          -  No prior chemotherapy for metastatic or recurrent disease

        Endocrine therapy

          -  No concurrent hormonal therapy

        Radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  More than 4 weeks since prior major surgery and recovered

          -  More than 6 months since vascular surgery, stenting, or angioplasty

        Other

          -  At least 4 weeks since prior and no concurrent sorivudine or brivudine

          -  More than 4 weeks since prior participation in any investigational drug study

          -  No prior therapy that affects or targets the epidermal growth factor pathway

          -  No concurrent cimetidine

               -  Concurrent ranitidine, famotidine, or proton-pump inhibitors allowed

          -  Concurrent anticoagulation therapy with full-dose anticoagulant allowed provided dose
             is stable for at least 2 weeks