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Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

Published: October 8, 2008

Primary Outcome Measures:

  • 4-month progression-free survival [ Designated as safety issue: N]

Secondary Outcome Measures:

  • Response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in patients with measurable disease by RECIST and modified RECIST criteria [ Designated as safety issue: N]
  • Overall survival [ Designated as safety issue: N]
  • Frequency and severity of toxicities [ Designated as safety issue: Yes ]


  • Primary
    • Tdetermine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus.
  • Secondary
    • Tdetermine the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in patients with measurable disease by RECIST and modified RECIST criteria.
    • Tdetermine overall survival of these patients.
    • Tevaluate the frequency and severity of toxicities associated with this treatment regimen.

Outline: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 3 years.

Eligibility Criteria

Disease Characteristics:
  • Histologically confirmed malignant pleural mesothelioma
    • Unresectable disease
  • Must have measurable or nonmeasurable disease by RECIST or modified RECIST criteria
  • Must have received prior systemically administeredplatinum-based chemotherapy and meets the following criteria:
    • Nmore than 2 prior systemic therapeutic regimens allowed (including biologics, targeted, and immunotherapies)
    • At least 1 regimen must have been platinum-based
    • Neoadjuvant and/or adjuvant systemic therapy is not counted as a prior regimen, assuming ≥ 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease NOTE: *Pleural space washing with cisplatin does not constitute systemic administration
  • Nknown CNS metastases
Patient Characteristics:
  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum bilirubin normal
  • AST or ALT ≤ 1.5 times upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Nevidence of bleeding diathesis or coagulopathy
    • Previous pulmonary embolism allowed provided the patient is on therapeutic low molecular weight heparin injections or warfarin AND nevidence of bleeding
      • Patients on therapueutic warfarin must have an INR of < 5 within 28 days prior tregistration
  • Npathologic condition other than mesothelioma that carries a high risk of bleeding
  • Nknown HIV positivity
  • Ngastrointestinal tract disease resulting in an inability ttake oral or enteral medication via a feeding tube or a requirement for IV alimentation, or active peptic ulcer disease
  • *Nother prior malignancy allowed except for any of the following:
    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which patient has been disease-free for 5 years
Prior Concurrent Therapy:
  • See Disease Characteristics
  • Recovered from all prior therapy
  • At least 28 days since prior systemic therapy (42 days for nitrosoureas or mitomycin C)
  • At least 28 days since prior thoracic or other major surgery (e.g., pleurectomy or pleurodesis) and nanticipated need for major surgical procedures during study
  • At least 14 days since prior radiotherapy
  • Nprior surgical procedure affecting absorption
  • Nprior chronic, systemic corticosteroids or other immunosuppressive agent, except corticosteroids equivalent tprednisone ≤ 20 mg daily
    • Must have been on a stable dosage regimen for ≥ 4 weeks
    • Topical and inhaled corticosteroids allowed
  • Nprior mTOR inhibitor therapy (i.e., rapamycin, everolimus, or temsirolimus)
  • Nconcurrent immunization with attenuated live vaccines
  • Nconcurrent antiretroviral therapy for HIV-positive patients
  • Nother concurrent investigational therapy
  • Nother concurrent anticancer agents
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