Clinical Trials /

Exemestane in Post-Menopausal Women With NSCLC

NCT02666105

Description:

This is a phase II therapeutic study of adding exemestane therapy in post-menopausal women with advanced non-small cell lung cancer (NSCLC) who are progressing while on treatment with an immune checkpoint antibody (pembrolizumab, atezolizumab, or nivolumab).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Exemestane in Post-Menopausal Women With NSCLC
  • Official Title: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2015LS095
  • NCT ID: NCT02666105

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
ExemestaneAromasinExemestane Therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Exemestane TherapyExperimental
  • Exemestane

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Response
Time Frame:Day 42
Safety Issue:
Description:Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).

Secondary Outcome Measures

Measure:Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4
Time Frame:30 days after the last dose of exemestane
Safety Issue:
Description:Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.
Measure:Response Duration
Time Frame:Day 42
Safety Issue:
Description:Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
Measure:Response Duration
Time Frame:Day 84
Safety Issue:
Description:Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
Measure:Response Duration
Time Frame:Day 126
Safety Issue:
Description:Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
Measure:Progression-free survival
Time Frame:1 year after enrollment
Safety Issue:
Description:Progression-free survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
Measure:Overall survival
Time Frame:Day 42
Safety Issue:
Description:Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
Measure:Overall survival
Time Frame:Day 84
Safety Issue:
Description:Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
Measure:Overall survival
Time Frame:Day 126
Safety Issue:
Description:Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
Measure:Quality of Life
Time Frame:Within 14 days of enrollment
Safety Issue:
Description:Quality of life will be assessed by use of PROMIS -29.
Measure:Quality of Life
Time Frame:Day 21
Safety Issue:
Description:Quality of life will be assessed by use of PROMIS -29.
Measure:Quality of Life
Time Frame:Day 42
Safety Issue:
Description:Quality of life will be assessed by use of PROMIS -29.
Measure:Quality of Life
Time Frame:Day 63
Safety Issue:
Description:Quality of life will be assessed by use of PROMIS -29.
Measure:Quality of Life
Time Frame:Day 84
Safety Issue:
Description:Quality of life will be assessed by use of PROMIS -29.
Measure:Quality of Life
Time Frame:Day 105
Safety Issue:
Description:Quality of life will be assessed by use of PROMIS -29.
Measure:Quality of Life
Time Frame:Day 126
Safety Issue:
Description:Quality of life will be assessed by use of PROMIS -29.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Masonic Cancer Center, University of Minnesota

Trial Keywords

  • NSCLC

Last Updated

August 15, 2016