Brief Title
S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
Official Title
Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
Brief Summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with
pleural malignant mesothelioma that cannot be removed by surgery.
Detailed Description
OBJECTIVES:
Primary
- To determine the 4-month progression-free survival in patients with unresectable
malignant pleural mesothelioma treated with everolimus.
Secondary
- 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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-Free Survival
Secondary Outcome
Response
Condition
Malignant Mesothelioma
Intervention
everolimus
Study Arms / Comparison Groups
Everolimus
Description: Daily oral Everolimus 10 mg/day
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
61
Start Date
December 2008
Completion Date
April 2014
Primary Completion Date
April 2014
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 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
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 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
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
Gender
All
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Sai-Hong I. Ou, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00770120
Organization ID
CDR0000616162
Secondary IDs
S0722
Responsible Party
Sponsor
Study Sponsor
Southwest Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Sai-Hong I. Ou, MD, PhD, Study Chair, Chao Family Comprehensive Cancer Center
Verification Date
February 2020