Exemestane in Post-Menopausal Women With NSCLC

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02666105
Collaborator
(none)
6
18
1
41.1
0.3
0

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date :
Sep 27, 2018
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exemestane Therapy

Drug: Exemestane
One 25 mg tablet once daily for a minimum of 6 weeks
Other Names:
  • Aromasin
  • Outcome Measures

    Primary Outcome Measures

    1. Disease Response [Day 42]

      Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).

    2. Disease Response [Day 84]

      Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).

    3. Disease Response [Day 126]

      Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).

    Secondary Outcome Measures

    1. Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4 [30 days after the last dose of exemestane]

      Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.

    2. Response Duration [Day 42]

      Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).

    3. Response Duration [Day 84]

      Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).

    4. Response Duration [Day 126]

      Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).

    5. Progression-free survival [1 year after enrollment]

      Progression-free survival will be assessed using the Response Criteria in Solid Tumors (RECIST).

    6. Overall survival [Day 42]

      Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).

    7. Overall survival [Day 84]

      Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).

    8. Overall survival [Day 126]

      Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).

    9. Quality of Life [Within 14 days of enrollment]

      Quality of life will be assessed by use of PROMIS -29.

    10. Quality of Life [Day 21]

      Quality of life will be assessed by use of PROMIS -29.

    11. Quality of Life [Day 42]

      Quality of life will be assessed by use of PROMIS -29.

    12. Quality of Life [Day 63]

      Quality of life will be assessed by use of PROMIS -29.

    13. Quality of Life [Day 84]

      Quality of life will be assessed by use of PROMIS -29.

    14. Quality of Life [Day 105]

      Quality of life will be assessed by use of PROMIS -29.

    15. Quality of Life [Day 126]

      Quality of life will be assessed by use of PROMIS -29.

    16. Quality of Life [1 month post discontinuation of study treatment]

      Quality of life will be assessed by use of PROMIS -29.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab) NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis

    • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase - tumor block or a minimum of 5 unstained slides

    • Failed at least 1 prior FDA approved treatment for advanced NSCLC. Patients with EGFR/ALK/ROS1 rearrangements should have received an FDA-approved TKI prior to enrollment on this trial.

    • Measureable disease by RECIST version 1.1

    • 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

    • Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record
    • Adequate organ function within 14 days of study enrollment defined as:

    • Hematology:

    ** Absolute neutrophil count (ANC) ≥ 1500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 8 g/dL

    • Biochemistry:

    • Total Bilirubin within normal institutional limits

    • 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.

    • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min

    • Must have recovered to CTCAE v 4 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:

    • 1 week from the completion of radiation therapy 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)

    • 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 - patients should be neurologically stable and requiring ≤10mg oral prednisone equivalence of steroids per day

    • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2

    • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Health System Albert Lea Minnesota United States 56007
    2 Essentia Health St. Joseph's Medical Center Brainerd Minnesota United States 56401
    3 Essentia Health Deer River Deer River Minnesota United States 56636
    4 Essentia Health St. Mary's Detroit Lakes Detroit Lakes Minnesota United States 56501
    5 Essentia Health Cancer Center Duluth Minnesota United States 55805
    6 Essentia Health Fosston Fosston Minnesota United States 56542
    7 Fairview Grand Itasca Clinic & Hospital Grand Rapids Minnesota United States 55744
    8 Essentia Health Hibbing Hibbing Minnesota United States 55746
    9 Fairview Range Medical Center Hibbing Minnesota United States 55746
    10 Mayo Clinic Health System Mankato Minnesota United States 56001
    11 Masonic Cancer Center, University of Minnesota Minneapolis Minnesota United States 55455
    12 Monticello Cancer Center (MMCORC) Monticello Minnesota United States 55362
    13 Essentia Health Park Rapids Park Rapids Minnesota United States 56470
    14 Fairview Northland Medical Center Princeton Minnesota United States 55731
    15 Essentia Health Sandstone Sandstone Minnesota United States 55072
    16 Sanford Thief River Falls Medical Center Thief River Falls Minnesota United States 56701
    17 Essentia Health Virginia Virginia Minnesota United States 55792
    18 Sanford Worthington Medical Center Worthington Minnesota United States 56187

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Principal Investigator: Manish Patel, DO, University of Minnesota Masonic Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT02666105
    Other Study ID Numbers:
    • 2015LS095
    First Posted:
    Jan 28, 2016
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Masonic Cancer Center, University of Minnesota
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2022