Skip to content
Triangle logo TriangleGet started
← Study library

NCT02283658 · REGISTRY CONDITION SEARCH

Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2020-10-23

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Percentage of Patients Alive and Progression Free Survival at 12 Weeks

→

outcome · POSTED

Percentage of Participants With CA-125 Response

→

outcome · POSTED

Confirmed Response Rate, Estimated Using RECIST 1.1 Criteria

→

outcome · POSTED

Number of Participants Experiencing Adverse Events

→

outcome · POSTED

Overall Suravival(OS)

→

outcome · POSTED

Progression Free Survival (PFS)

→

outcome · NOT POSTED

Expression of Molecular Biomarkers Associated With a Response to Treatment With Letrozole and Everolimus in Patients With Relapsed Ovarian Carcinomas

→

outcome · NOT POSTED

Response Rates to Letrozole and Everolimus in PDX Avatars

→

outcome · NOT POSTED

Responsiveness of Tumors to Letrozole and Everolimus

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
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 =\< 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)
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: Everolimus
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Letrozole
    label
    Treatment (everolimus and letrozole)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (everolimus and letrozole)
    description
    Given PO
    name
    Everolimus
    other Names
    1. 42-O-(2-Hydroxy)ethyl Rapamycin
    2. Afinitor
    3. Certican
    4. RAD 001
    5. RAD001
    type
    DRUG
  2. arm Group Labels
    1. Treatment (everolimus and letrozole)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  3. arm Group Labels
    1. Treatment (everolimus and letrozole)
    description
    Given PO
    name
    Letrozole
    other Names
    1. CGS 20267
    2. Femara
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    The Fisher's Exact test will be used to measure the associations.
    measure
    Expression of Molecular Biomarkers Associated With a Response to Treatment With Letrozole and Everolimus in Patients With Relapsed Ovarian Carcinomas
    time Frame
    28 days following treatment initiation
  2. description
    Will determine if response rates to letrozole and everolimus in PDX avatars correlate to responses noted in the patients. The Fisher's Exact test will be used to measure the associations.
    measure
    Response Rates to Letrozole and Everolimus in PDX Avatars
    time Frame
    28 days following treatment initiation
  3. description
    "Response" will be defined as tumors with at least a 50% reduction in tumor volume at study end. "Unresponsive" will be defined as tumors with less than 10% tumor volume reduction at study end. Intermediate values will be defined as "Stable". Tumor growth curves will be plotted graphically and notated to indicate the outcome status of the originating patients. End of study tumor volumes will be correlated with outcome status of the originating patient as well. The Fisher's Exact test will be used to measure the associations.
    measure
    Responsiveness of Tumors to Letrozole and Everolimus
    time Frame
    28 days following treatment initiation
primary Outcomes
  1. 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.
    measure
    Percentage of Patients Alive and Progression Free Survival at 12 Weeks
    time Frame
    12 weeks
secondary Outcomes
  1. description
    CA-125 response: The key secondary endpoint of the study will be a CA-125 response, defined as a 50% or greater reduction in baseline CA-125. The null hypothesis will be set at CA-125 response rate of 8.3%, based on the response of single agent letrozole, as reported by Bowman et al (7). The treatment of letrozole and everolimus will be considered promising, based on CA-125, if the observed CA-125 response rate is 30% or more.
    measure
    Percentage of Participants With CA-125 Response
    time Frame
    Up to 2 years
  2. description
    A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. A complete response (CR) in evaluable patients will be defined as: * Disappearance of any sign of (evaluable) disease, AND * Normalization of CA-125; if CA-125 normalizes, it should be confirmed at any time. A partial response (PR) in evaluable patients will be defined as: * Decrement in CA-125 by \>50%, and * Improvement in any additional evaluable disease (if present) as assessed by the enrolling physician.
    measure
    Confirmed Response Rate, Estimated Using RECIST 1.1 Criteria
    time Frame
    Up to 24 weeks
  3. description
    The number of patients with adverse events.The maximum grade for each type of adverse event (AE) will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns. These tables are reported in the adverse events section of this report.
    measure
    Number of Participants Experiencing Adverse Events
    time Frame
    Up to 30 days post-treatment
  4. description
    OS will be estimated using the method of Kaplan-Meier.
    measure
    Overall Suravival(OS)
    time Frame
    Time from registration to death from any cause, assessed up to 2 years
  5. description
    PFS will be estimated using the method of Kaplan-Meier. 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.
    measure
    Progression Free Survival (PFS)
    time Frame
    Time from registration to the first of either disease progression or death from any cause, assessed up to 2 years
Full study description
brief 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.
detailed Description
PRIMARY OBJECTIVES: I. Demonstrate that the combination of letrozole and everolimus leads to a higher percentage of patients who are free of progression at 12 weeks (PFS 12) as compared with that observed in a previously reported phase 2 trial of letrozole alone for relapsed ovarian carcinomas. SECONDARY OBJECTIVES: I. Cancer antigen (CA)-125 response, progression-free survival (PFS), overall survival (OS), the confirmed response rate, and adverse events. TERTIARY OBJECTIVES: I. Identify molecular biomarkers associated with a response to treatment with letrozole and everolimus in patients with relapsed ovarian carcinomas. II. Develop and determine if response rates to letrozole and everolimus in patient derived xenograft (PDX) avatars correlate to responses noted in the patients. OUTLINE: Patients receive everolimus orally (PO) once daily (QD) and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-172d3c9848d4205d9bf6
      requested nct id
      NCT02283658
      primary nct id
      NCT02283658
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
      payload sha256
      3ab20df16d7a06211e52db38e855443a19c689ae2cd3f31a7397456987aca97b
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-172d3c9848d4205d9bf6
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02283658
      occurrences
      1. context exact
        NCT02283658
        end
        11
        exact text
        NCT02283658
        start
        0
      offset unit
      unicode_code_points
      query cond
      Ovarian Germ Cell Tumors
      query disease state id
      ds-ovarian-germ-cell-tumors
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-ovarian-germ-cell-tumors-000.json
      source file sha256
      359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
      source json pointer
      /studies/79/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      d863e2fe357f692bc8598c4997628b03fd145e13ee600d665098eb35bd5bb7dc

    Preserved source evidence · Not medical advice