A Phase 2 interventional study of Letrozole in Leiomyosarcoma and Uterine Neoplasm, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is learn if taking Femara (letrozole) after a hysterectomy (surgical removal of the uterus) for uterine leiomyosarcoma will delay or prevent the cancer from coming back.
Letrozole is an aromatase inhibitor. Aromatase is the enzyme that produces estrogen in post-menopausal women. By interfering with the production of estrogen triggered by aromatase, letrozole reduces the total amount of estrogen in the body. As a result, less estrogen can reach cancer cells, thus preventing their growth.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. These exams, tests, or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.
Your complete medical history will be recorded, and you will have a physical exam (including a pelvic exam). Your vital signs and blood pressure will be measured. Blood (about 2-3 teaspoons) will be drawn for routine tests. You will also have a blood test (1 teaspoon) to check your cholesterol. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will also have a chest x-ray, and either a computed tomography (CT) scan or a magnetic resonance imaging (MRI) to check the status of the disease. Your doctors will test previously collected tumor tissue to learn if the estrogen receptor is positive or negative.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. Group 1 will receive letrozole by mouth once a day. Group 2 will receive no treatment. Both groups will be followed closely every 3 months. You will have an equal chance of being placed in either group.
If you are in Group 1, you will take letrozole by mouth every day for 12 weeks. Every 12 weeks is considered a study "cycle." You will only be given the amount of drug needed for 1 cycle of therapy at a time. You will keep a diary during the study that will list when and how much drug you took. This diary will be reviewed after each cycle of therapy by the research nurse or doctor and filed in your chart.
Every 12 weeks, all participants will have blood (about 3-4 teaspoons) drawn for routine tests. CT scan of the chest, abdomen (stomach area), and pelvis will be done every 24 weeks. In addition, all participants will have a physical exam (including a pelvic exam), and your vital signs and blood pressure will be measured.
You may remain on study for as long as you are benefitting. You will be taken off study if intolerable side effects occur.
Once you are off study, blood (about 2-3 teaspoons) will be drawn for routine tests and to measure your cholesterol level. You will have a physical exam (including a pelvic exam), and an MRI or CT scan.
This is an investigational study. Letrozole is approved by the FDA for treatment of some breast cancer patients after surgery. Its use in patients with leiomyosarcoma is experimental. Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
147 studies on the registry are indexed under Leiomyosarcoma; 33 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 121 interventional studies indexed under Leiomyosarcoma.
Browse Leiomyosarcoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks.
Drug: Letrozole
Patients receive no treatment. Follow up every 3 months.
2.5 mg Tablet By Mouth Daily for 12 Weeks.
Also known as: Femara
Progression Free Survival (PFS)
Number of participants progressed or death from study entry.
Time frame: Every 12 weeks
Randomized (adaptive), open-label phase II of Letrozole (experimental) vs. observation (control) in patients with clinical stage I or stage II leiomyosarcoma
| Milestone | Letrozole | Standard of Care |
|---|---|---|
| Started | 4 | 5 |
| Completed | 1 | 0 |
| Not completed | 3 | 5 |
| Withdrew: Progression | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Adverse event | 1 | 0 |
Number of participants progressed or death from study entry.
| Participants | Letrozole | Standard of Care |
|---|---|---|
| Progression Free Survival (PFS) | 1 | 2 |
Collected over From study entry to time of progression or death. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Letrozole | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Standard of Care | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Event | Letrozole | Standard of Care |
|---|---|---|
| Hot FlashesEndocrine disorders | 4/4 | 0/5 |
| FatigueMusculoskeletal and connective tissue disorders | 3/4 | 0/5 |
| CholesterolMetabolism and nutrition disorders | 2/4 | 0/5 |
| DiarrheaGastrointestinal disorders | 2/4 | 0/5 |
| Mood Alteration (depression)Psychiatric disorders | 2/4 | 0/5 |
| Pain (muscle)Musculoskeletal and connective tissue disorders | 2/4 | 0/5 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/4 | 0/5 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/4 | 0/5 |
| BilirubinMetabolism and nutrition disorders | 1/4 | 0/5 |
| ConstipationGastrointestinal disorders | 1/4 | 0/5 |
| Age, Categorical(Participants) | Letrozole | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 5 | 9 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Letrozole | Standard of Care | Total |
|---|---|---|---|
| Mean | 48 (43 to 54) | 51 (38 to 60) | 49 (38 to 60) |
| Sex: Female, Male(Participants) | Letrozole | Standard of Care | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Letrozole | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Letrozole | Standard of Care | Total |
|---|---|---|---|
| United States | 4 | 5 | 9 |
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This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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