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Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
This study is currently recruiting participants.
Verified April 2011 by National Cancer Institute (NCI)

First Received on October 8, 2008.   Last Updated on April 6, 2011   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00770120
  Purpose

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 Intervention Phase
Malignant Mesothelioma
Drug: everolimus
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 4-month progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Frequency and severity of toxicities [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: December 2008
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 therapueutic 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770120

  Show 126 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Sai-Hong I. Ou, MD, PhD Chao Family Comprehensive Cancer Center
Investigator: Linda Garland, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier: NCT00770120     History of Changes
Other Study ID Numbers: CDR0000616162, SWOG-S0722
Study First Received: October 8, 2008
Last Updated: April 6, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent malignant mesothelioma
advanced malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2012