Clinical trial · Interventional
S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
NCT00770120CI-TRIAL-00043846completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Daily oral Everolimus 10 mg/day
- interventionNames
- Drug: everolimus
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- Every 8 weeks until disease progression, up to 3 years.
- 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
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 agentsReferences
Publications (1)
- RESULTOu SH, Moon J, Garland LL, Mack PC, Testa JR, Tsao AS, Wozniak AJ, Gandara DR. SWOG S0722: phase II study of mTOR inhibitor everolimus (RAD001) in advanced malignant pleural mesothelioma (MPM). J Thorac Oncol. 2015 Feb;10(2):387-91. doi: 10.1097/JTO.0000000000000360. PMID 25611229