Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery

Inclusion Criteria

• Histologically confirmed unresectable malignant melanoma
• Radiographic or clinical evidence of metastatic disease
• Measurable disease with ≥ 1 lesion whose longest diameter can be measured as ≥ 2.0 cm by CT or MRI scans or ≥ 1.0 cm by spiral CT scan
• Disease that is measurable by physical examination only is not allowed
• No known intraluminal metastatic lesion(s) with suspected bleeding
• No brain metastases by MRI or CT scan
• ECOG performance status 0-2
• Life expectancy > 12 weeks
• WBC ≥ 3,000/μL
• Hemoglobin ≥ 9 g/dL
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Serum troponin normal
• Urine protein ≤ 1+ (≤ 30 mg/dL) on 2 consecutive dipstick or other urine assessments taken ≥ 1 week apart
• QTc interval 140 mm Hg and diastolic BP > 90 mm Hg)
• No condition that impairs ability to swallow and retain pazopanib hydrochloride (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would or might reasonably be expected to limit compliance with study requirements
• No admission for unstable angina, cardiac angioplasty, or stenting within the past 6 months
• More than 6 weeks since prior major surgery
• More than 4 weeks since prior and no concurrent radiotherapy
• At least 14 days or 5 half-lives and no concurrent CYP interactive medications
• No prior radiotherapy to ≥ 25% of bone marrow
• No prior therapy with a VEGFR tyrosine-kinase inhibitor
• No concurrent antiretroviral therapy for HIV-positive patients
• No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib hydrochloride
• No concurrent chemotherapy
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies
• No concurrent medications that are associated with a risk of QTc prolongation and/or Torsades de Pointes