Clinical trial NCT00604461 (phase 1/phase 2, status: terminated)
Conditions: mesothelioma
ICD codes: C45.9, C45.0, C45.1, C45.2, C45.7
Drugs: carboplatin, bevacizumab and pemetrexed
SMILES: [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have histologically proven diagnosis of Malignant Pleural Mesothelioma
             (MPM)

          -  Patient must have MPM with measurable disease.

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0,
             1, or 2.

          -  Patient must have adequate renal function with a serum creatinine level of less than
             1.5 mg/dl and patient should have a calculated creatinine clearance of more than
             40ml/min.

          -  Patient must have adequate hepatic function with a serum bilirubin level of less that
             3mg/dl, and an alkaline phosphatase, ALT and AST of less than five times the upper
             limit of normal

          -  Patient must also have evidence of adequate bone marrow function with an absolute
             neutrophil count of more than 1500 cells per deciliter and a platelet count of more
             than 100,000 per deciliter.

          -  Patients must be more than 28 days since prior open biopsy; more than 7 days since
             prior fine-needle aspiration; more than 7 days since prior core biopsy; more than 28
             days since prior surgery.

          -  Patients must be able to take dexamethasone, folic acid, and vitamin B-12
             supplementation.

          -  All patients must sign informed consent that will detail the investigational nature of
             the study in accordance with the institutional and federal guidelines.

          -  Patients with clinically significant pleural effusions or ascites (symptomatic or
             detectable by clinical exam) should have their effusions drained prior to enrollment
             on the clinical trial.

        Exclusion Criteria:

          -  Patients with hypercalcemia (corrected calcium of more than 11 mg/dl) will be
             excluded.

          -  Patients with history of hemoptysis, haematemesis, coagulopathy or thrombosis will be
             excluded.

          -  Patients requiring anticoagulation for any reason will be excluded.

          -  History of palliative radiation therapy within 2 weeks

          -  Blood pressure of >160/100 mmHg, despite adequate anti-hypertensive use.

          -  Currently ongoing unstable angina

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure.

          -  History of stroke within 6 months

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to the day of initiation of treatment, anticipation of need for major surgical
             procedure during the course of the study

          -  Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to the day of initiation of treatment.

          -  Pregnant (positive pregnancy test) or lactating

          -  Urine calculated creatinine clearance of less than 40ml/minute. - History of abdominal
             fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
             prior to Day 0

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Inability to comply with study and/or follow-up procedures

        Laboratory Values:

          -  Patient must have adequate renal function with a serum creatinine level of less than
             1.5 mg/dl and patient should have a calculated creatinine clearance of more than
             40ml/min.

          -  Patient must have adequate hepatic function with a serum bilirubin level of less than
             3 mg/dl, and an alkaline phosphatase, ALT and AST of less than five times the upper
             limit of normal

          -  Patient must also have evidence of adequate bone marrow function with an absolute
             neutrophil count of more than 1, 500 cells per deciliter and a platelet count of more
             than 100,000 per deciliter.