Clinical trial NCT01217398 (phase 2, status: unknown status)
Conditions: intraocular melanoma
ICD codes: Z96.1, T85.22XS, T85.21XS, T85.22XA, T85.22XD, T85.21XA, T85.21XD
Drugs: temozolomide
SMILES: CSCC[C@H](N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed uveal melanoma

               -  Metastatic disease

          -  Measurable disease, defined as ≥ 1 measurable lesion as measured by RECIST criteria

          -  No curative surgical treatment envisaged

          -  No active brain metastases (if clinical suspicion, must have a brain CT scan within 28
             days)

        PATIENT CHARACTERISTICS:

          -  WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%

          -  Life expectancy ≥ 12 weeks

          -  Hemoglobin ≥ 10 g/dL

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine
             clearance ≥ 50 mL/min

          -  Proteinuria < 2+ on urinary dipstick OR 24-hour proteinuria ≤ 1 g

          -  Total bilirubin ≤ 1.5 times ULN

          -  AST/ALT ≤ 2.5 times ULN

          -  Lactate dehydrogenase ≤ 5 times ULN

          -  INR and PT ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study treatment

          -  No uncontrolled active disease or at risk of bleeding, ongoing infection, or clotting
             disorder

          -  No other cancer except for skin carcinomas and cervical carcinoma in situ

          -  No pre-existing peripheral neuropathy, > grade 2 (NCI CTC-AE)

          -  No failure to comply with the medical follow-up of the study for geographical, social,
             or psychological reasons

          -  No recent thrombophlebitis or pulmonary embolism within the past 6 months

          -  No uncontrolled hypertension (systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg)

          -  No concurrent active cardiovascular disease, uncontrolled by medical treatment within
             the past 6 months, including any of the following:

               -  Unstable angina

               -  Severe hypertension

               -  Severe arrhythmia

          -  No unhealed wound, active peptic ulcer, bone fracture, history of abdominal fistula,
             gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

          -  No known hypersensitivity to bevacizumab, temozolomide, or their excipients

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy for metastatic disease

          -  At least 24 hours since insertion of central infusion port

          -  More than 5 days since prior non-hepatic biopsy or aspiration cytology

          -  More than 10 days since prior aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or
             full-dose oral or parenteral anticoagulant therapy, except prophylactic anticoagulant
             therapy prior to inclusion in the study

          -  More than 14 days since prior laparoscopic liver biopsy

          -  More than 28 days since prior major surgery

          -  More than 28 days since prior participation in another study with experimental
             treatment

          -  No other concurrent anticancer treatment