S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
Condition: Advanced Malignant Mesothelioma; Epithelial Mesothelioma; Recurrent Malignant Mesothelioma; Sarcomatous Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms
Intervention: cediranib maleate; laboratory biomarker analysis
Intervention description: Given orally; Correlative studies
Intervention MeSH terms: Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is study how well AZD2171 works in treating patients with malignant
      pleural mesothelioma that cannot be removed by surgery. AZD2171 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 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