Overview

This trial is active, not recruiting.

Condition malignant mesothelioma
Treatment everolimus
Phase phase 2
Targets mTOR, FKBP-12
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date December 2008
End date May 2013
Trial size 55 participants
Trial identifier NCT00770120, CDR0000616162, S0722, U10CA032102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Daily oral Everolimus 10 mg/day
everolimus

Primary Outcomes

Measure
Progression-Free Survival
time frame: Every 8 weeks until disease progression

Secondary Outcomes

Measure
Response
time frame: Every 8 weeks while on protocol treatment.
Overall Survival
time frame: Weekly during the first 8 weeks of treatment, then every 3 weeks while on treatment, then every 8 weeks until disease porgression, then every 6 months thereafter.
Frequency and severity of toxicities
time frame: From date of registration to 3 years post registration or death (whichever occurs first)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.