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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

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