Clinical Trials for Mesothelioma Patients—Sorafenib, Pemetrexed, and Cisplatin: Outcome Measures: Patient Characteristics

Read about the patient characteristics for a current clinical trial about the use of Sorafenib, Pemetrexed, and Cisplatin for patients with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only

Patient Characteristics Criteria:

• Menopausal status not specified
• ECOG performance status 0-1
• ANC = 1.5 x 10^9/L
• Platelet count = 100 x 10^9/L
• Hemoglobin = 9 g/dL
• Bilirubin = 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase = 3 times ULN (5 times ULN if liver has tumor involvement)
• AST and ALT = 3 times ULN (5 times ULN if liver has tumor involvement)
• Serum creatinine = 1.5 mg/dL
• Creatinine clearance > 45 mL/min
• INR < 1.5 OR PT/PTT normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 2 weeks after completion of study treatment
• Able to take folic acid and vitamin B_12
• Able to take oral medications without crushing, dissolving, or chewing tablets
• No malabsorption problem
• No other condition that impairs the patient's ability to swallow whole pills
• No New York Heart Association class III-IV congestive heart failure
• No unstable angina (anginal symptoms at rest) or new onset angina within the past 3 months
• No myocardial infarction within the past 6 months
• No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
• No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months
• No pulmonary hemorrhage/bleeding event = CTCAE grade 2 within the past 4 weeks
• No other hemorrhage/bleeding event = CTCAE grade 3 within the past 4 weeks
• No evidence or history of bleeding diathesis or coagulopathy
• No known or suspected allergy to sorafenib tosylate, pemetrexed disodium, cisplatin, or any agent given in the course of this study
• No known HIV infection or chronic hepatitis B or C infection
• No active clinically serious infection > CTCAE grade 2
• No serious nonhealing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 4 weeks
• No peripheral neuropathy = CTCAE grade 2
• No second primary malignancy except in situ carcinoma of the cervix or breast or other in situ malignancies, adequately treated basal cell carcinoma of the skin, or other malignancy treated at least 3 years ago with no evidence of recurrence

Courtesy of ClinicalTrials.gov, a service of the U.S. National Institutes of Health

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