Ovarian CancerPhase 2NCT02188550
Single Arm Trial With Combination of Everolimus and Letrozole in Treatment of Platinum Resistant Relapse or Refractory or Persistent Ovarian Cancer/Endometrial Cancer
A Phase 2 study testing everolimus and letrozole in people with Ovarian Cancer and Endometrial Cancer, run by Sinai Hospital of Baltimore at 1 site in United States.
Trial summary
The purpose of the study is to determine if the combination of Everolimus and Letrozole is effective in the treatment of women with either recurrent or persistent epithelial ovarian, fallopian tube, primary peritoneal or endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer
- What is being tested?
- everolimus and letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal or post-oophorectomy.
- Performance status Less than or equal to ECOG 2
- Patients must have relapse or refractory or persistent epithelial ovarian, fallopian tube, primary peritoneal carcinoma or endometrial cancer. Histologic documentation of the original primary tumor is required via pathology report.
- Patients must have received treatment with a platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin. This initial treatment may have included intraperitoneal therapy, consolidation, noncytotoxic agents (biologic/targeted therapy) or extended therapy administered after surgical or non-surgical assessment.
- Patients must have platinum-resistant disease, defined as progression < 12 months after completion of first-or-second-line platinum based chemotherapy. The date (platinum-free interval) should be calculated from the last administered dose of platinum therapy.
- Platinum sensitive patients must have progressed/relapsed after receiving a second line platinum therapy.
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- Patients with platinum-refractory primary disease, defined as having disease3 progression while receiving first-line platinum-based chemotherapy.
- Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of relapse or refractory or persistent disease.
- Patients are allowed to have received, but are not required to have received, biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their primary treatment regimen or for management of relapse or refractory or persistent disease.
Who cannot join
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of Everolimus (including chemotherapy, antibody based therapy, etc.); radiation therapy within 2 weeks.
- Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g.
- sirolimus, temsirolimus) or to Letrozole.
- Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral Everolimus;
- Patients who have any severe and/or uncontrolled medical conditions such as:
- unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
Show all 11Show fewer
- Symptomatic congestive heart failure of New York heart Association Class III or IV
- active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active or chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),
- known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),
- active, bleeding diathesis;
- Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, 21215
Judy Bosley, BSN, RN, 410-601-6120, jbosley@lifebridgehealth.org
Melissa Loomis, 410-601-6120, mloomis@lifebridgehealth.org
About this study
Official title: Phase II Single Arm Trial With Combination of Everolimus and Letrozole in Treatment of Platinum Resistant Relapse or Refractory or Persistent Ovarian Cancer/Endometrial Cancer (CRAD001CUS242T)
The purpose of the study is to determine if the combination of Everolimus and Letrozole is effective in the treatment of women with either recurrent or persistent epithelial ovarian, fallopian tube, primary peritoneal or endometrial cancer.
Experiments have shown that everolimus (Afinitor®) can prevent cells such as cancer from growing in number. Therefore, everolimus (Afinitor®) is being tested in specific diseases to stop cells from growing too fast (as in cancer).
Read more
Everolimus (Afinitor®) has been FDA approved for adults with advanced kidney cancer (Renal Cell Carcinoma). Everolimus (Afinitor®) received approval for patients with subependymal giant cell astrocytoma (SEGA), a brain tumor seen with genetic conditions called tuberous sclerosis complex (TSC) who require therapy, but are not candidates for surgery. Everolimus (Afinitor®) was approved for pancreatic neuroendocrine tumor (PNET) in patients with unresectable, locally advanced, or metastatic disease. Everolimus (Afinitor®) received approval for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. Everolimus (Afinitor®) also received approval for the treatment of patients with TSC who have renal angiomyolipoma not requiring immediate surgery.
Everolimus (Afinitor®) has been used to treat patients in clinical studies since 2002 and approximately 25,645 patients (as of 30-Sep-2012) have been treated with everolimus (Afinitor®).
Read the detailed description
This is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented.
Subjects will take two pills once a day by mouth with a glass of water.
Before the study…
Subjects will need to have the following exams, tests or procedures to find out if they can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if subjects do not join the study. If subjects have had some of them recently, they may not need to be repeated. This will be up to your study doctor.
- Medical history risk and physical examination,
- Blood tests to measure blood counts, blood mineral levels, and check liver and kidney function,
- CT scan or MRI of the abdomen and pelvis to measure detectable tumor
- A pregnancy blood test if subjects are capable of becoming pregnant
- Urinalysis (examination of urine)
- The European Organization for research and treatment of cancer global quality of life questionnaire C30 (QLQ-C30) -This standard questionnaire helps us to measure quality of life. This questionnaire will take subjects 15 minutes to complete and will be completed at entry into the study and at week 12 and 24 during the study.
Tests will be done for hepatitis B and/or C if:
- Subjects have a risk of having hepatitis B and/or C or if subjects live or have lived in specific geographical areas, such as Asia, Africa, Central and South America, Eastern Europe and Spain, Portugal or Greece;
- The study doctor thinks it is appropriate.
Subjects that have positive hepatitis B or hepatitis C results at screening may be required to take medication for up to 2 weeks before they start everolimus (Afinitor®) treatment.
During the Study…
If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will need the following tests and procedures. They are part of regular cancer care.
- History and physical examination
- Weekly blood tests to measure blood counts, blood mineral levels, blood clotting and check liver and kidney function
- Evaluation of side effects subjects may experience from the study treatment
- Tests to having hepatitis B and/or C
- CT scan or MRI of the abdomen and pelvis every 12 weeks
- The European Organization for research and treatment of cancer global quality of life questionnaire C30 (QLQ-C30)
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Being tested
- everolimus and letrozole
- Keywords
- relapse or refractory or persistent epithelial ovarian fallopian tube, primary peritoneal carcinoma or endometrial cancer
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimus and letrozoleDrug
This is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented
The duration of the study will be until disease progression
Everolimus and Letrozole will be administered as noted below;
6.1.1 Dosing regimen
Dosage : Everolimus Dose: 10 Unit: mg Frequency: daily Route of administration: Orally Dosage : Letrozole Dose: 2.5 Unit: mg Frequency: daily Route of administration: Orally
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | This is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented Receives: Drug: everolimus and letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria
The duration of response will be documented and also compared to the duration of response ot the last, most recent, cancer treatment.
Measured: Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months
Secondary outcomes (1)
Overall survival of patients treated with the combination of letrozole and everolimus
Measured: From randomization until date of death, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai Hospital of Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Miller, M.D., Sinai Hospital of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188550
- Sponsor's protocol ID
- CRAD001CUS242T
- Status last verified
- May 2015
- First submitted
- 9 May 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single Arm Trial With Combination of Everolimus and Letrozole in Treatment of Platinum Resistant Relapse or Refractory or Persistent Ovarian Cancer/Endometrial Cancer (CRAD001CUS242T)
- ClinicalTrials.gov ID
- NCT02188550
- Acronym / sponsor ID
- CRAD001CUS242T
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Keywords
- relapse or refractory or persistent epithelial ovarian fallopian tube, primary peritoneal carcinoma or endometrial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sinai Hospital of BaltimoreUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if the combination of Everolimus and Letrozole is effective in the treatment of women with either recurrent or persistent epithelial ovarian, fallopian tube, primary peritoneal or endometrial cancer.
Experiments have shown that everolimus (Afinitor®) can prevent cells such as cancer from growing in number. Therefore, everolimus (Afinitor®) is being tested in specific diseases to stop cells from growing too fast (as in cancer).
Everolimus (Afinitor®) has been FDA approved for adults with advanced kidney cancer (Renal Cell Carcinoma). Everolimus (Afinitor®) received approval for patients with subependymal giant cell astrocytoma (SEGA), a brain tumor seen with genetic conditions called tuberous sclerosis complex (TSC) who require therapy, but are not candidates for surgery. Everolimus (Afinitor®) was approved for pancreatic neuroendocrine tumor (PNET) in patients with unresectable, locally advanced, or metastatic disease. Everolimus (Afinitor®) received approval for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. Everolimus (Afinitor®) also received approval for the treatment of patients with TSC who have renal angiomyolipoma not requiring immediate surgery.
Everolimus (Afinitor®) has been used to treat patients in clinical studies since 2002 and approximately 25,645 patients (as of 30-Sep-2012) have been treated with everolimus (Afinitor®).
Detailed description
This is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented.
Subjects will take two pills once a day by mouth with a glass of water.
Before the study…
Subjects will need to have the following exams, tests or procedures to find out if they can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if subjects do not join the study. If subjects have had some of them recently, they may not need to be repeated. This will be up to your study doctor.
- Medical history risk and physical examination,
- Blood tests to measure blood counts, blood mineral levels, and check liver and kidney function,
- CT scan or MRI of the abdomen and pelvis to measure detectable tumor
- A pregnancy blood test if subjects are capable of becoming pregnant
- Urinalysis (examination of urine)
- The European Organization for research and treatment of cancer global quality of life questionnaire C30 (QLQ-C30) -This standard questionnaire helps us to measure quality of life. This questionnaire will take subjects 15 minutes to complete and will be completed at entry into the study and at week 12 and 24 during the study.
Tests will be done for hepatitis B and/or C if:
- Subjects have a risk of having hepatitis B and/or C or if subjects live or have lived in specific geographical areas, such as Asia, Africa, Central and South America, Eastern Europe and Spain, Portugal or Greece;
- The study doctor thinks it is appropriate.
Subjects that have positive hepatitis B or hepatitis C results at screening may be required to take medication for up to 2 weeks before they start everolimus (Afinitor®) treatment.
During the Study…
If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will need the following tests and procedures. They are part of regular cancer care.
- History and physical examination
- Weekly blood tests to measure blood counts, blood mineral levels, blood clotting and check liver and kidney function
- Evaluation of side effects subjects may experience from the study treatment
- Tests to having hepatitis B and/or C
- CT scan or MRI of the abdomen and pelvis every 12 weeks
- The European Organization for research and treatment of cancer global quality of life questionnaire C30 (QLQ-C30)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Drug: everolimus and letrozoleThis is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Post-menopausal or post-oophorectomy.
- Performance status Less than or equal to ECOG 2
- Patients must have relapse or refractory or persistent epithelial ovarian, fallopian tube, primary peritoneal carcinoma or endometrial cancer. Histologic documentation of the original primary tumor is required via pathology report.
- Patients must have received treatment with a platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin. This initial treatment may have included intraperitoneal therapy, consolidation, noncytotoxic agents (biologic/targeted therapy) or extended therapy administered after surgical or non-surgical assessment.
- Patients must have platinum-resistant disease, defined as progression < 12 months after completion of first-or-second-line platinum based chemotherapy. The date (platinum-free interval) should be calculated from the last administered dose of platinum therapy.
Key exclusion criteria (11 listed)
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of Everolimus (including chemotherapy, antibody based therapy, etc.); radiation therapy within 2 weeks.
- Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g.
- sirolimus, temsirolimus) or to Letrozole.
- Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral Everolimus;
- Patients who have any severe and/or uncontrolled medical conditions such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everolimus and letrozoleThis is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented The duration of the study will be until disease progression Everolimus and Letrozole will be administered as noted below; 6.1.1 Dosing regimen Dosage : Everolimus Dose: 10 Unit: mg Frequency: daily Route of administration: Orally Dosage : Letrozole Dose: 2.5 Unit: mg Frequency: daily Route of administration: Orally | Drug | Single |
Primary outcome
Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria
Time frame: Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months
The duration of response will be documented and also compared to the duration of response ot the last, most recent, cancer treatment.
1 secondary outcome
Overall survival of patients treated with the combination of letrozole and everolimus
Time frame: From randomization until date of death, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus and letrozole in people with Ovarian Cancer and Endometrial Cancer, run by Sinai Hospital of Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria (time frame: Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.