Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma
Condition: Malignant Peritoneal Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: erlotinib hydrochloride
Intervention description: Given PO
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people
      with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer.
      Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other
      cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This
      research is being done because there is no current standard treatment for malignant
      peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant
      peritoneal mesothelioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically- or cytologically-confirmed malignant peritoneal mesothelioma;
             epithelial, sarcomatoid, biphasic, or well-differentiated papillary subtypes are
             allowed.

          -  A tumor block or 10 unstained slides must be available for determining EGFR mutational
             status; only those patients who have a mutation of the EGFR tyrosine kinase domain
             will be able to enroll in this study.

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT)
             scan.

          -  No prior use of EGFR tyrosine kinase inhibitors or monoclonal antibodies; all other
             prior treatments are allowed if >= 4 weeks since treatment completed, including
             chemotherapy (systemic or intraperitoneal), radiation therapy, and/or surgery; there
             is no limit on the number of previous treatments allowed.

          -  Life expectancy of greater than 3 months.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Leukocytes >= 2,000/mcL.

          -  Absolute neutrophil count >= 1,500/mcL.

          -  Platelets >= 100,000/mcL.

          -  Total bilirubin =< 1.5 X institutional upper limit of normal (ULN).

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<
             2.5 X institutional ULN.

          -  Creatinine =< 2 X institutional ULN OR creatinine clearance >= 30 mL/min/1.73 m^2 for
             patients with creatinine levels above institutional normal.

          -  The effects of erlotinib on the developing human fetus at the recommended therapeutic
             dose are unknown; for this reason, women of child-bearing potential and men must agree
             to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry and for the duration of study participation; should a
             woman become pregnant or suspect she is pregnant while participating in this study,
             she should inform her treating physician immediately.

          -  Ability to understand and the willingness to sign a written informed screening and
             treatment consent.

        Exclusion Criteria:

          -  Chemotherapy, radiotherapy, or surgery within 4 weeks (6 weeks for nitrosoureas or
             mitomycin C) prior to entering the study or those who have not recovered from adverse
             events due to agents administered more than 4 weeks earlier.

          -  Patients may not be receiving any other investigational agents.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop. progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to erlotinib.

          -  EGFR-mutation negative tumor tissue as determined by sequencing; if an individual
             tissue test result is inconclusive (unable to be determined), it will be considered
             negative for study eligibility purposes.

          -  History of previous malignancy excluding non-melanoma skin lesions and in-situ
             cervical cancer; patients with other malignancies are eligible if they have been
             disease free for >= 3 years.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnant women are excluded from this study because it is unknown if erlotinib poses a
             potential for teratogenic or abortifacient effects; because there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with erlotinib, breastfeeding should be discontinued if the mother is treated
             with erlotinib.

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible because of the potential for pharmacokinetic interactions with
             erlotinib; in addition, these patients are at increased risk of lethal infections;
             appropriate studies will be undertaken in patients receiving combination
             antiretroviral therapy when indicated.

          -  Inability to tolerate or absorb an oral medication due to any cause, including but not
             limited to malabsorption syndromes.