vatalanib in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery

Conditions: Melanoma (Skin)

Summary: rationale: vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.

objectives: primary * to determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib. secondary * to determine the time to progression in these patients. * to determine the 6-month and 1-year survival of these patients. * to determine the overall survival of these patients. * to determine the safety and toxicity of this drug in these patients. outline: this is a multicenter study. patients receive oral vatalanib twice daily on days 1-28. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. after completion of study therapy, patients are followed at 8 weeks and then periodically thereafter.

Eligibility criteria:
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

Keywords: stage iv melanoma recurrent melanoma