Phase 2
N=20
Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Ovarian Endometrioid Adenocarcinoma · Ovarian Seromucinous Carcinoma · Ovarian Serous Cystadenocarcinoma · Ovarian Serous Surface Papillary Adenocarcinoma · Recurrent Fallopian Tube Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02283658 ↗Enrolled (actual)
20
Serious AEs
52.6%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Patients Alive and Progression Free Survival at 12 Weeks — 47 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus (Drug); Laboratory Biomarker Analysis (Other); Letrozole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Alive and Progression Free Survival at 12 Weeks |
47 | — |
| SECONDARY Percentage of Participants With CA-125 Response |
21 | — |
| SECONDARY Confirmed Response Rate, Estimated Using RECIST 1.1 Criteria |
16 | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
19 | — |
| SECONDARY Overall Suravival(OS) |
13 | — |
| SECONDARY Progression Free Survival (PFS) |
3.9 | — |
Summary
This pilot, phase II trial studies how well everolimus and letrozole work in treating patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back. Everolimus and letrozole may stop the growth of tumor cells by blocking some the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed estrogen receptor positive (greater than 10%) recurrent ovarian, fallopian tube or primary peritoneal carcinoma in post-menopausal women; note: pure clear cell and pure mucinous carcinomas are ineligible; both platinum sensitive, platinum resistant and platinum refractory disease are eligible; no limitations in the number of prior regimens
- Patient has disease amenable to biopsy and is agreeable to undergo a biopsy; note: under unusual circumstances, submission of ascites material may be acceptable if a biopsy is not possible; this will require approval by one of the study principal investigators
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin > 9.0 g/dL
- Total serum bilirubin = 8% despite adequate therapy; note: patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary
- Chronic treatment with corticosteroids or other immunosuppressive agents; note: topical or inhaled corticosteroids are allowed
- Patients who have received live attenuated vaccines =< 1 week prior to registration and during the study; note: patient should also avoid close contact with others who have received live attenuated vaccines; examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guerin (BCG), yellow fever, varicella and TY21a typhoid vaccines
- History of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
- Prior therapy with everolimus or an aromatase inhibitor
- Known brain metastasis
- Active and chronic viral hepatitis (i.e. quantifiable serum hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B virus surface antigen [HBsAg], or quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA] in serum)
Data sourced from ClinicalTrials.gov (NCT02283658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.