S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Advanced Malignant Mesothelioma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural mesothelioma Unresectable disease Residual disease after prior cytoreductive surgery allowed Measurable disease by CT scan or MRI Prior treatment with platinum-based chemotherapy required No known CNS metastasis Performance status Zubrod 0-2 WBC >= 3,000/mm^3 Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 AST or ALT =< 1.5 times upper limit of normal (ULN) Bilirubin normal Creatinine =< 1.5 times ULN OR Creatinine clearance >= 50 mL/min Proteinuria =< 1+ by 2 consecutive dipstick tests taken >= 1 week apart No history of familial long QT syndrome Mean QTc =< 470 msec Systolic BP =< 150 mm Hg AND diastolic BP =< 100 mm Hg Must have New York Heart Association class I or II disease Class II must be controlled with treatment Able to swallow and/or receive enteral medications via gastrostomy feeding tube Not requiring IV alimentation No active peptic ulcer No intractable nausea or vomiting Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in remission No history of hypersensitivity reaction to compounds of similar chemical or biological composition to the study drug Prior monoclonal antibody therapy targeting vascular endothelial growth factor (VEGF), VEGF receptor 1(VEGFR1) or VEGF receptor 2 (VEGFR2) allowed No other prior immunotherapy or biologic therapy No prior thymidine kinase inhibitor against VEGFR1 or VEGFR2 No concurrent drugs or biologics with proarrhythmic potential No more than 1 prior chemotherapy regimen At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered At least 21 days since prior radiotherapy and recovered At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and recovered No prior surgery that would affect absorption Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are met Concurrent enrollment on SWOG-S9925 allowed No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Southwest Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.