S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
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.
Checked against the public recordLast updated Mar 6, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- SWOG Cancer Research Network
- Interventions being studied
- Drug: everolimus
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
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.