Clinical trial · Interventional
Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Phase 2 Trial of Letrozole and Everolimus in Relapsed Hormone Receptor Positive Ovarian, Fallopian Tube or Primary Peritoneal Carcinomas
NCT02283658CI-TRIAL-00047902completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Endometrioid Adenocarcinoma | Ovarian Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Seromucinous Carcinoma | Ovarian Seromucinous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Serous Cystadenocarcinoma | Ovarian Serous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Serous Surface Papillary Adenocarcinoma | Primary Peritoneal Serous Papillary Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | CURATED_BROADER | 0.78 |
| Recurrent Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (everolimus and letrozole)
- description
- Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Everolimus
- Other: Laboratory Biomarker Analysis
- Drug: Letrozole
Primary outcomes (1)
- measure
- Percentage of Patients Alive and Progression Free Survival at 12 Weeks
- timeFrame
- 12 weeks
- description
- The percentage of PFS12 successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Disease progression in evaluable patients will be defined as one or more of the following: * Any new disease and/or clear progression of evaluable disease; OR * 2 fold elevation in CA-125 from its lowest level (either initial level or nadir, whichever is lowest, since study enrollment) combined with CA-125 elevation confirmed by re-assay at any time.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 =\< 2 mg/dL * Aspartate transaminase (AST) =\< 2.5 x upper limit of normal (ULN) (=\< 5 x ULN in patients with liver metastasis) * International normalized ratio (INR) =\< 2 * Creatinine =\< 1.5 x ULN * Fasting serum cholesterol =\< 300 mg/dL or =\< 7.75 mmol/L and fasting triglycerides =\< 2.5 x ULN; in case of any of these thresholds be exceeded, the patient can only be included after initiation of appropriate lipid lowering medications * Provide informed written consent * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willing to provide tissue samples for correlative research purposes Exclusion Criteria: * Any of the following * Pregnant women * Nursing women * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens including but not limited to any of the following that would limit compliance with study requirements: * Ongoing or active severe infection * Liver disease such as cirrhosis * Decompensated liver disease * Symptomatic congestive heart failure (New York heart Association class III or IV) * Unstable angina pectoris, serious uncontrolled cardiac arrhythmia, myocardial infarction =\< 6 months prior to registration * Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide \[DLCO\] 50% or less of normal and oxygen \[O2\] saturation 88% or less at rest on room air) * Active bleeding diathesis * Psychiatric illness * Known to be human immunodeficiency virus (HIV) positive * Receiving any other investigational agent =\< 4 weeks prior to registration which would be considered as treatment for the primary neoplasm * Other active malignancy =\< 3 years prior to registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix, uterus or breast; note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer * Patients currently receiving anticancer therapies or who have received anticancer therapies =\< 4 weeks prior to registration (including chemotherapy, radiation therapy, antibody based therapy, etc.) * Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus) * Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus * Uncontrolled diabetes mellitus as defined by hemoglobin (Hb)A1c \> 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)
References
Publications (0)
Data not yet available
No reference posted for this study.