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Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)

Phase 2
18 Years
Open (Enrolling)
Malignant Mesothelioma

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Trial Information

Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)



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


- 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.

- To determine overall survival of these patients.

- To evaluate the frequency and severity of toxicities associated with this treatment

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.

Inclusion Criteria


- 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


- 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 therapeutic 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


- See Disease Characteristics

- Recovered from all prior therapy

- At least 28 days since prior systemic therapy (42 days for nitrosoureas or mitomycin

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Description:

Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a >= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease

Outcome Time Frame:

Every 8 weeks until disease progression

Safety Issue:


Principal Investigator

Sai-Hong I. Ou, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2008

Completion Date:

June 2013

Related Keywords:

  • Malignant Mesothelioma
  • recurrent malignant mesothelioma
  • stage II malignant mesothelioma
  • stage III malignant mesothelioma
  • stage IV malignant mesothelioma
  • Mesothelioma



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