Status:
COMPLETED
S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Mesothelioma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 patient...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00770120
Start Date
December 1 2008
End Date
April 1 2014
Last Update
March 6 2020
Active Locations (129)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
2
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
3
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States, 95901
4
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868