Clinical trial NCT00423696 (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, fluorouracil, irinotecan hydrochloride, leucovorin calcium
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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed colorectal cancer

               -  Unresectable metastatic disease

          -  Measurable disease

          -  No CNS metastases

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Life expectancy > 3 months

          -  Absolute neutrophil count > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Hemoglobin > 9 g/dL (transfusion allowed)

          -  INR < 1.5

          -  Alkaline phosphatase < 1.5 times upper limit of normal (ULN)

          -  Bilirubin < 1.5 times ULN

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

          -  Creatinine clearance > 30 mL/min

          -  Urine protein < 2+ OR ≤ 1 g/L by 24-hour urine collection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No contraindications to study therapy

          -  No gastrointestinal or duodenal ulcers

          -  No AIDS

          -  No serious illness, active infection, or other serious condition that would preclude
             study therapy

          -  No coagulation problem

          -  No bleeding diathesis

          -  No sensitivity to Chinese hamster ovarian cells or other recombinant human antibodies

          -  No severe renal insufficiency

          -  No uncontrolled hypertension

          -  No active or severe cardiovascular conditions, including the following:

               -  Cerebrovascular accident

               -  Myocardial infarction within the past 6 months

               -  New York Heart Association class II-IV cardiac insufficiency

               -  Severe cardiac arrhythmia (even if treated)

          -  No primitive stenosis or symptomatic peritoneal carcinosis causing a risk of
             intestinal subocclusion or occlusion

          -  No nonhealing wound or fracture

          -  No prior thromboembolic disease

          -  No other cancer within the past 2 years except for basal cell skin cancer or carcinoma
             in situ of the uterine cervix

          -  No geographical, social, or psychological condition that would preclude study
             participation

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy for metastatic disease

          -  At least 6 months since prior adjuvant chemotherapy (fluorouracil with or without
             oxaliplatin)

               -  No prior adjuvant chemotherapy comprising irinotecan hydrochloride with or
                  without bevacizumab

          -  At least 28 days since prior major surgery

          -  Prior radiotherapy allowed except to target lesions

          -  At least 10 days since prior anticoagulants

          -  No concurrent chronic acetylsalicylic acid (at doses > 325 mg/day)

          -  No other concurrent investigational therapy

          -  No other concurrent anticancer therapy