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

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma Read More

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