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

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.

Tracking Information
First Received DateOctober 8, 2008
Last Changed DateJanuary 10, 2017
Start DateDecember 2008
Actual Primary Completion DateApril 2014
Primary Outcome Measures

Progression-Free Survival [Time Frame: Every 8 weeks until disease progression, up to 3 years.]

Secondary Outcome Measures

Response [Time Frame: Every 8 weeks until disease progression, up to 3 years.]

Overall Survival [Time Frame: Every 8 weeks until disease progression, up to 3 years.]

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.]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Malignant Mesothelioma
Intervention
  • Drug: everolimus
Study Arms / Comparison Groups1 / 0
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment61
GenderAll
Ages18 Years - 120 Years
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT00770120
Responsible Party,
SponsorSouthwest Oncology Group
Verification DateJanuary 2017
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