LeiomyosarcomaPhase 2NCT00856050
Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
A Phase 2 study testing letrozole in people with Leiomyosarcoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyosarcoma
- What is being tested?
- letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed, advanced estrogen (ER)/progesterone receptor (PR) positive leiomyosarcoma of uterine origin, for which standard multi-modality curative therapies do not exist or are no longer effective
- Patients must be postmenopausal. Postmenopausal is defined as any of the following: 1)Bilateral oophorectomy 2) 60 years of age or older 3)Younger than 60 AND amenorrheic for 12 months or more AND follicle stimulating hormone (FSH) and estradiol (E2) within postmenopausal range 4)Ovarian ablation radiotherapy confirmed by FSH and estradiol (E2) level in the postmenopausal range
- Evidence of ER and/or PR positivity, either in primary or secondary tumor tissue
- Measurable disease outside of a prior irradiated area as defined by RECIST guidelines. A lesion in a previously irradiated area is not eligible for measurable diseae unless there is objective evidence of progression of the lesion prior to study enrollment
- 18 years of age or older
- Life expectancy of 3 months or more
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- ECOG Performance Status 0, 1, or 2
- No limit to number of prior chemotherapies or biologics
- Normal organ function as outlined in the protocol
- Resolution of clinically significant toxicities related to prior therapies
Who cannot join
- Pre-menopausal women
- Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
- Palliative radiotherapy within 2 weeks of study entry
- Major surgery within 2 weeks of study entry
- Prior hormonal therapy for the treatment of uterine leiomyosarcoma (prior hormone replacement therapy is allowed)
- Participants may not be receiving any other concomitant investigational agents
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- Uncontrolled brain or central nervous system metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
The purpose of this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone levels in the body, it may be helpful to control tumors that express hormone receptors ( ER/PR).
Read the detailed description
- Participants will take letrozole orally once a day. During the research study the following tests and procedures will be performed:
- Visit 1 (Day 1): physical examination, vital signs and blood work
- Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan
- Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan
- Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse
- Conditions
- Leiomyosarcoma
- Being tested
- letrozole
- Keywords
- estrogen receptor positive, progesterone receptor positive, letrozole
- Medical subject headings
- Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letrozoleDrug
Also called Femara
Taken orally once a day continuously
| Study group | Role | What they receive |
|---|---|---|
| letrozole | Experimental | single arm trial - all patients received letrozole 2.5mg by mouth per day Receives: Drug: letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Rate at 12 Weeks
Data below are reported as progression free rate (%).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis
- Responsible party
- Principal investigator, Suzanne George, MD, Dana-Farber Cancer Institute
- Investigators
- Suzanne George, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856050
- Sponsor's protocol ID
- 08-341
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2009
- Last updated
- 18 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
- ClinicalTrials.gov ID
- NCT00856050
- Acronym / sponsor ID
- 08-341
- Conditions
- Leiomyosarcoma
- Keywords
- estrogen receptor positive, progesterone receptor positive, letrozole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis
- Study start
- Feb 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Posted 19 Mar 2014
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 this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone levels in the body, it may be helpful to control tumors that express hormone receptors ( ER/PR).
Detailed description
- Participants will take letrozole orally once a day. During the research study the following tests and procedures will be performed:
- Visit 1 (Day 1): physical examination, vital signs and blood work
- Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan
- Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan
- Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| letrozole | Experimental | Drug: letrozolesingle arm trial - all patients received letrozole 2.5mg by mouth per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed, advanced estrogen (ER)/progesterone receptor (PR) positive leiomyosarcoma of uterine origin, for which standard multi-modality curative therapies do not exist or are no longer effective
- Patients must be postmenopausal. Postmenopausal is defined as any of the following: 1)Bilateral oophorectomy 2) 60 years of age or older 3)Younger than 60 AND amenorrheic for 12 months or more AND follicle stimulating hormone (FSH) and estradiol (E2) within postmenopausal range 4)Ovarian ablation radiotherapy confirmed by FSH and estradiol (E2) level in the postmenopausal range
- Evidence of ER and/or PR positivity, either in primary or secondary tumor tissue
- Measurable disease outside of a prior irradiated area as defined by RECIST guidelines. A lesion in a previously irradiated area is not eligible for measurable diseae unless there is objective evidence of progression of the lesion prior to study enrollment
- 18 years of age or older
Key exclusion criteria (10 listed)
- Pre-menopausal women
- Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
- Palliative radiotherapy within 2 weeks of study entry
- Major surgery within 2 weeks of study entry
- Prior hormonal therapy for the treatment of uterine leiomyosarcoma (prior hormone replacement therapy is allowed)
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 |
|---|---|---|
| letrozoleAlso: FemaraTaken orally once a day continuously | Drug | letrozole |
Primary outcome
Progression Free Survival Rate at 12 Weeks
Time frame: 12 weeks
Data below are reported as progression free rate (%).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suzanne George, MD principal investigator
Dana-Farber Cancer Institute
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 letrozole in people with Leiomyosarcoma, run by Dana-Farber Cancer Institute 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 18 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival Rate at 12 Weeks (time frame: 12 weeks). 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 18 Apr 2017.