Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. To determine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus.

Secondary

1. To determine 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.
2. To determine overall survival of these patients.
3. To evaluate the frequency and severity of toxicities associated with this treatment regimen.

Entry 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 administered* platinum-based chemotherapy and meets the following criteria:
  • No more 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]

• No known CNS metastases

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 no anticipated need for major surgical procedures during study
• At least 14 days since prior radiotherapy
• No prior surgical procedure affecting absorption
• No prior chronic, systemic corticosteroids or other immunosuppressive agent, except corticosteroids equivalent to prednisone ≤ 20 mg daily
  • Must have been on a stable dosage regimen for ≥ 4 weeks
  • Topical and inhaled corticosteroids allowed
• No prior mTOR inhibitor therapy (i.e., rapamycin, everolimus, or temsirolimus)
• No concurrent immunization with attenuated live vaccines
• No concurrent antiretroviral therapy for HIV-positive patients
• No other concurrent investigational therapy
• No other concurrent anticancer agents

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
• No evidence of bleeding diathesis or coagulopathy
  • Previous pulmonary embolism allowed provided the patient is on therapeutic low molecular weight heparin injections or warfarin AND no evidence of bleeding
    • Patients on therapueutic warfarin must have an INR of < 5 within 28 days prior to registration
• No pathologic condition other than mesothelioma that carries a high risk of bleeding
• No known HIV positivity
• No gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for IV alimentation, or active peptic ulcer disease
• No other 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

Expected Enrollment

Outcomes

4-month progression-free survival

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
Overall survival
Frequency and severity of toxicities

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Sai-Hong Ou, MD, PhD, Protocol chair		Ph: 714-456-8104 Email: siou@uci.edu
Linda Garland, MD, Protocol co-chair		Ph: 520-626-3434; 800-622-2673 Email: lgarland@azcc.arizona.edu

Registry Information
Official Title		Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
Trial Start Date		2008-12-01
Trial Completion Date		2011-02-15 (estimated)
Registered in ClinicalTrials.gov		NCT00770120
Date Submitted to PDQ		2008-09-29
Information Last Verified		2011-09-16
NCI Grant/Contract Number		CA32102

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