TriangleNCT00770120 · REGISTRY CONDITION SEARCH
S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2020-03-06
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- maximum Age
- 120 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Daily oral Everolimus 10 mg/day
- intervention Names
- Drug: everolimus
- label
- Everolimus
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Everolimus
- name
- everolimus
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 61
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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
- measure
- Progression-Free Survival
- time Frame
- Every 8 weeks until disease progression, up to 3 years.
- secondary Outcomes
- description
- A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a \>= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.
- measure
- Response
- time Frame
- Every 8 weeks until disease progression, up to 3 years.
- description
- Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
- measure
- Overall Survival
- time Frame
- Every 8 weeks until disease progression, up to 3 years.
- measure
- Frequency and Severity of Toxicities
- time Frame
- Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.
Full study description
- 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.
Source references
- references
- citation
- Ou 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
- type
- RESULT
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice