Clinical Trials for Mesothelioma Patients: Pazopanib Patient Characteristics

Read the patient characteristics criteria about a current clinical trial being conducted to study the effects of Pazopanib for patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Patient Characteristics:

? ECOG performance status 0-2

? Life expectancy = 12 weeks

? ANC =1,500/mm³

? Platelet count = 100,000/mm³

? WBC = 3,000/mm³

? Bilirubin = 1.5 times upper limit of normal (ULN)

? AST and ALT = 2.5 times ULN

? Alkaline phosphatase = 2.5 times ULN

? Creatinine = 1.5 times ULN or creatinine clearance = 50 mL/min

? Proteinuria = 1+ on 2 consecutive dipsticks taken = 1 week apart

? PT/INR/PTT = 1.2 times ULN

? Not pregnant or nursing

? Negative pregnancy test

? Fertile patients must use effective nonhormonal contraception

? No uncontrolled infection

? No uncontrolled blood pressure (BP) (defined as systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg in spite of adequate anti-hypertensive therapy)

? No condition that impairs ability to swallow and retain study drug tablets including, but not limited to, any of the following: o Gastrointestinal tract disease resulting in an inability to take oral medication o Requirement for IV alimentation o Prior surgical procedures affecting absorption o Active peptic ulcer disease

? No other severe underlying disease that, in the judgment of the investigator, would limit study compliance

? No other primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated = 5 years ago with no subsequent evidence of recurrence o Patients with a history of low-grade (Gleason score = 6) localized prostate cancer are eligible even if diagnosed within the past 5 years

? No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study

? None of the following concurrent severe and/or uncontrolled medical conditions: o Serious or nonhealing wound, ulcer, or bone fracture o Abdominal fistula, diverticulosis, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days o Poorly controlled diabetes o Interstitial pneumonia o Extensive and symptomatic interstitial fibrosis of the lung

? No cardiovascular illness or complication, including any of the following: o Any history of cerebrovascular accident within the past 6 months o History of myocardial infarction (prior electrocardiographic evidence of myocardial injury) o History of cardiac arrhythmia (prior electrocardiographic evidence of abnormal heart rhythm) o Admission for unstable angina o Cardiac angioplasty or stenting within the past 12 months o NYHA class III-IV heart failure

? Asymptomatic NYHA class II heart failure allowed o QTc prolongation (defined as a QTc interval = 500 msecs) or other significant electrocardiogram abnormalities o Venous thrombosis within the past 12 weeks ? No symptomatic, untreated, or uncontrolled seizure disorder

? No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit study compliance

? No significant traumatic injury within the past 4 weeks

Courtesy of ClinicalTrials.gov.

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