Exemestane in Post-Menopausal Women With NSCLC
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Exemestane Therapy
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Drug: Exemestane
One 25 mg tablet once daily for a minimum of 6 weeks
Other Names:
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Outcome Measures
Primary Outcome Measures
- Disease Response [Day 42]
Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Disease Response [Day 84]
Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Disease Response [Day 126]
Initial disease response will be assessed using the Response Criteria in Solid Tumors (RECIST).
Secondary Outcome Measures
- 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.
- Response Duration [Day 42]
Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Response Duration [Day 84]
Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Response Duration [Day 126]
Response duration will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Progression-free survival [1 year after enrollment]
Progression-free survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Overall survival [Day 42]
Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Overall survival [Day 84]
Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Overall survival [Day 126]
Survival will be assessed using the Response Criteria in Solid Tumors (RECIST).
- Quality of Life [Within 14 days of enrollment]
Quality of life will be assessed by use of PROMIS -29.
- Quality of Life [Day 21]
Quality of life will be assessed by use of PROMIS -29.
- Quality of Life [Day 42]
Quality of life will be assessed by use of PROMIS -29.
- Quality of Life [Day 63]
Quality of life will be assessed by use of PROMIS -29.
- Quality of Life [Day 84]
Quality of life will be assessed by use of PROMIS -29.
- Quality of Life [Day 105]
Quality of life will be assessed by use of PROMIS -29.
- Quality of Life [Day 126]
Quality of life will be assessed by use of PROMIS -29.
- Quality of Life [1 month post discontinuation of study treatment]
Quality of life will be assessed by use of PROMIS -29.
Eligibility Criteria
Criteria
Inclusion Criteria
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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
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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
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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.
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Measureable disease by RECIST version 1.1
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Post-menopausal defined as
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Age ≥ 55 years and 1 year or more of amenorrhea
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Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL
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Surgical menopause with bilateral oophorectomy
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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
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Adequate organ function within 14 days of study enrollment defined as:
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Hematology:
** Absolute neutrophil count (ANC) ≥ 1500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 8 g/dL
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Biochemistry:
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Total Bilirubin within normal institutional limits
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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.
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Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min
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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.
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A minimum time period must elapse between the end of a previous treatment and start of study therapy:
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1 week from the completion of radiation therapy for brain metastases
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4 weeks from the completion of chemotherapy or any experimental therapy
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4 weeks from prior major surgery (such as open biopsy or significant traumatic injury)
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Voluntary written consent before any research related procedures or therapy
Exclusion Criteria
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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
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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
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Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity
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Inability or unwilling to swallow study drug
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Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
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Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e. black cohosh)
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Known hypersensitivity to exemestane or its excipients
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Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment
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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
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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 | |
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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.- 2015LS095