S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedeverolimus

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 6, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?129 U.S. locations

Locations may change over time.

Who runs it?SWOG Cancer Research Network

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: SWOG Cancer Research Network
Interventions being studied: Drug: everolimus

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Treatment approach

Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California
Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California
Valley Medical Oncology Consultants - PleasantonPleasanton, California
University of California Davis Cancer CenterSacramento, California
San Luis Valley Regional Medical CenterAlamosa, Colorado
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado
Shaw Regional Cancer CenterEdwards, Colorado
Valley View Hospital Cancer CenterGlenwood Springs, Colorado
Montrose Memorial Hospital Cancer CenterMontrose, Colorado
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 6, 2020. Always confirm current availability with the study team.

View original record ↗