Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
Condition: Advanced Malignant Mesothelioma; Epithelial Mesothelioma; Localized Malignant Mesothelioma; Recurrent Malignant Mesothelioma; Sarcomatous Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms
Intervention: cediranib maleate
Intervention description: Given orally
Intervention MeSH terms: Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well cediranib maleate works in treating patients with
      malignant mesothelioma that cannot be removed by surgery. Cediranib maleate 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 or cytologically confirmed malignant pleural, peritoneal, or tunica
             vaginalis mesothelioma

               -  Epithelial, sarcomatoid, or mixed subtype

          -  International Mesothelioma Interest Group stage II-IV disease (for patients with
             pleural mesothelioma)

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR > 10 mm by spiral CT scan

               -  Pleural effusion and ascites are not considered measurable lesions

          -  Disease not amenable to curative surgery

          -  No known brain metastases

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS
             70-100%

          -  Life expectancy > 3 months

          -  White blood cell (WBC) ≥ 3,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Hemoglobin ≥ 8 g/dL

          -  Platelets ≥ 100,000/mm³

          -  Total bilirubin normal

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper
             limit of normal(ULN)

          -  Creatinine normal OR creatinine clearance > 60 mL/min

          -  Fertile patients must use effective contraception

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No history of allergic reactions to compounds of similar chemical or biologic
             composition to AZD2171

          -  Mean corrected QT interval (QTc) ≤ 500 msec (with Bazett's correction) by EKG

          -  No history of long QT syndrome

          -  Proteinuria ≤ 1+ on two consecutive dipsticks taken ≥ 1 week apart

          -  No other concurrent malignancy

          -  No New York Heart Association class III or IV cardiac disease

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following:

               -  Hypertension

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situations that would limit study compliance

          -  No more than 1 prior cytotoxic chemotherapy

               -  Prior intrapleural cytotoxic agents (including bleomycin) do not count towards
                  prior cytotoxic chemotherapy

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
             and recovered

          -  No prior radiotherapy to the only site of measurable disease

          -  At least 4 weeks since prior radiotherapy and recovered

          -  At least 4 weeks since prior major surgery and recovered

          -  More than 30 days since prior participation in an investigational trial

          -  No prior treatment with a vascular endothelial growth factor (VEGF) inhibitor

          -  No other concurrent investigational agents

          -  No concurrent commercial agents for the malignancy

          -  No concurrent medication that may markedly affect renal function (e.g., vancomycin,
             amphotericin, or pentamidine)

          -  No concurrent hematopoietic growth factors except epoetin alfa

          -  No concurrent palliative radiotherapy

          -  No combination antiretroviral therapy for HIV-positive patients

          -  No concurrent drugs or biologics with proarrhythmic potential