S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00770120|
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : March 1, 2017
Last Update Posted : March 6, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: everolimus||Phase 2|
- To determine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Daily oral Everolimus 10 mg/day
- Progression-Free Survival [ Time Frame: Every 8 weeks until disease progression, up to 3 years. ]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
- Response [ Time Frame: Every 8 weeks until disease progression, up to 3 years. ]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.
- Overall Survival [ Time Frame: Every 8 weeks until disease progression, up to 3 years. ]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.
- 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. ]
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|Ages Eligible for Study:||18 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770120
|Study Chair:||Sai-Hong I. Ou, MD, PhD||Chao Family Comprehensive Cancer Center|
|Study Chair:||Linda Garland, MD||University of Arizona|
|Responsible Party:||Southwest Oncology Group|
|Other Study ID Numbers:||
S0722 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
|First Posted:||October 9, 2008 Key Record Dates|
|Results First Posted:||March 1, 2017|
|Last Update Posted:||March 6, 2020|
|Last Verified:||February 2020|
recurrent malignant mesothelioma
stage II malignant mesothelioma
stage III malignant mesothelioma
stage IV malignant mesothelioma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Physiological Effects of Drugs