Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Exemestane in Post-Menopausal Women With NSCLC

Summary: This is a phase II single institutional therapeutic study of exemestane in post-menopausal women with advanced non-small cell lung cancer (NSCLC) who have failed at least 1, but not more than 3 previous treatment regimens.


Eligibility: Inclusion Criteria:
  -  Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis
  -  Treated with at least 1 and a maximum of 3 prior chemotherapy regimens for advanced NSCLC. NOTE:
  -  If the tumor is refractory (progressed) after a prior chemotherapy regimen, then that regimen would count.
  -  If a prior chemotherapy regimen has been changed due to other reasons than disease progression (e.g. poor tolerance, allergic reaction), then it would not count as a separate prior regimen.
  -  A chemotherapy drug added for "maintenance" following disease stabilization or response to a chemotherapy regimen (in the absence of prior disease progression) does not count as a separate prior regimen.
  -  Chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed in <1 year counts as 1 prior regimen.
  -  Measureable disease by RECIST version 1.1 (appendix III)
  -  Post-menopausal defined as
  -  Age ≥ 55 years and 1 year or more of amenorrhea
  -  Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL
  -  Surgical menopause with bilateral oophorectomy
  -  ECOG performance status 0, 1 or 2 (appendix II)
  -  Adequate organ function within 14 days of study enrollment defined as
  -  Hematology:
  1. Absolute neutrophil count (ANC) ≥ 1500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL
  2. International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution
  -  Biochemistry:
  1. Total Bilirubin within normal institutional limits
  2. AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
  3. Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min
  -  Must have recovered to CTCAE grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e. peripheral neuropathy) is permitted
  -  A minimum time period must elapse between the end of a previous treatment and start of study therapy:
  -  3 weeks from the completion of radiation therapy for recurrent/metastatic disease (2 weeks for brain metastases)
  -  4 weeks from the completion of chemotherapy or any experimental therapy
  -  4 weeks from prior major surgery (such as open biopsy or significant traumatic injury)
  -  2 weeks from prior minor surgical procedures (such as chemotherapy infusion port placement or core visceral organ biopsy)
  -  Tissue block or slides available from most recent resection or original diagnosis
  -  Voluntary written consent before any research related procedures or therapy
  Exclusion Criteria:
  -  Known active CNS disease - If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery and be stable on repeat imaging - patients should be neurologically stable and on a stable or tapering dose of corticosteroids
  -  Known diagnosis of osteoporosis
  -  Inability or unwilling to swallow study drug
  -  Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
  -  Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e. black cohosh)
  -  Known hypersensitivity to exemestane or its excipients
  -  Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment
  -  Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval
  -  Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane

Relevance to patient case: not relevant