Clinical Trial Details

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Study ID NCI-2009-01163
Investigator
Amy Weise,   Mayo Clinic
Title Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery
Conditions Recurrent Melanoma
Stage IV Melanoma
Interventions Drug: pazopanib hydrochloride
Other: pharmacological study
Other: laboratory biomarker analysis
Phase Phase 2
Purpose This phase II trial is studying the side effects of pazopanib hydrochloride and to see how well it works in treating patients with metastatic melanoma that cannot be removed by surgery. Pazopanib hydrochloride 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
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 < 480 msec
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant ECG abnormalities (e.g., frequent ventricular ectopy, evidence of ongoing myocardial ischemia)
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history of abdominal fistula, gastrointestinal perforation, active diverticulitis, intra-abdominal abscess, or gastrointestinal tract bleeding within the past 28 days
  • No history of myocardial infarction, cardiac arrhythmia within the past 6 months
  • No NYHA class III-IV heart failure - Patients with a history of class II heart failure and who are asymptomatic on treatment may be eligible
  • No history of bleeding disorder, including hemophilia, disseminated intravascular coagulation, or any other abnormality of coagulation potentially predisposing patients to bleeding
  • No uncontrolled infection
  • No evidence of active bleeding or bleeding diathesis
  • No hemoptysis within 6 weeks of first dose of study drug
  • No active peptic ulcer disease
  • No inflammatory bowel disease
  • No ulcerative colitis or other gastrointestinal conditions with increased risk of perforation
  • No history of cerebrovascular accident, including transient ischemic attack, pulmonary embolism, or untreated deep venous thrombosis within the past 6 months - Patients with recent deep vein thrombosis who have been treated with therapeutic anticoagulating agents within the past 6 weeks are eligible
  • No known endobronchial lesions or involvement of large pulmonary vessels by tumor
  • No current active hepatic or biliary disease, except Gilbert syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease
  • No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 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
  • Study Location
    Mayo Clinic
    Rochester, Minnesota, 55905
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 10/23/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00861913


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