Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed metastatic cutaneous melanoma
• * Unresectable disease
• Measurable disease, defined as ≥ 1 bidimensionally measurable lesion by clinical or radiological techniques (i.e., chest x-ray, CT scan, or conventional MRI scan) using RECIST criteria
• No history or presence of CNS disease (i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases, or carcinomatous meningitis)
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Hemoglobin ≥ 10 g/dL
• Platelet count ≥ 100,000/mm\^3
• WBC ≥ 3,000/mm\^3
• ANC ≥ 1,500/mm\^3
• Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 x ULN (≤ 5 if liver metastases are present)
• Transaminases ≤ 3 x ULN (≤ 5 if liver metastases are present)
• Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
• Total urinary protein ≤ 500 mg by 24-hour urine collection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• No history of other malignant disease except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other serious or uncontrolled illness which, in the opinion of the investigator, precludes study entry
• No medical or psychiatric condition that precludes giving informed consent
• No history of renal disease (e.g., glomerulonephritis) or renal vascular disease
• No acute or chronic active liver disease (e.g., hepatitis or cirrhosis)
• No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following:
• * Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
• * Unstable angina pectoris
• * Symptomatic congestive heart failure
• * Myocardial infarction within the past 6 months
• * Serious uncontrolled cardiac arrhythmia
• * Uncontrolled diabetes
• * Active or uncontrolled infection
• No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib including, but not limited to, any of the following conditions:
• * Ulcerative disease
• * Uncontrolled nausea
• * Vomiting
• * Diarrhea which might result in malabsorption
• * Any known malabsorption syndrome
• * Bowel obstruction
• * Inability to swallow the capsules/tablets
• PRIOR CONCURRENT THERAPY:
• Recovered from all prior therapy
• Prior adjuvant therapy allowed
• Prior radiotherapy allowed
• * Measurable target lesions must not have been irradiated
• No more than one line of prior systemic therapy for advanced melanoma
• More than 4 weeks since prior chemotherapy, immunotherapy, or investigational agent
• More than 2 weeks since prior surgery
• No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system
• * Concurrent heparin allowed
• Concurrent radiotherapy for symptomatic disease is allowed, provided the lesions being irradiated contribute ≤ 20% of the sum of the longest diameter for all target lesions being used to determine response