Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

Inclusion 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