Trial Outcomes & Findings for Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma (NCT NCT00414076)
NCT ID: NCT00414076
Last Updated: 2018-11-20
Results Overview
Number of participants progressed or death from study entry.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Every 12 weeks
Results posted on
2018-11-20
Participant Flow
Randomized (adaptive), open-label phase II of Letrozole (experimental) vs. observation (control) in patients with clinical stage I or stage II leiomyosarcoma
physical exam, vital signs, ECG, laboratory tests, chest x-ray, CT or MRI
Participant milestones
| Measure |
Letrozole
Letrozole only
|
Standard of Care
Standard of Care-Patients receive no treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Letrozole
Letrozole only
|
Standard of Care
Standard of Care-Patients receive no treatment.
|
|---|---|---|
|
Overall Study
Progression
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
Baseline characteristics by cohort
| Measure |
Letrozole
n=4 Participants
Letrozole only
|
Standard of Care
n=5 Participants
Standard of Care-Patients receive no treatment.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
n=5 Participants
|
51 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 12 weeksPopulation: 1 out of 4 participants in the Letrozole arm progressed on study. 2 participants progressed in standard of care
Number of participants progressed or death from study entry.
Outcome measures
| Measure |
Letrozole
n=4 Participants
Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks.
Letrozole: 2.5 mg Tablet By Mouth Daily for 12 Weeks.
|
Standard of Care
n=5 Participants
Patients receive no treatment. Follow up every 3 months.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
1 Participants
|
2 Participants
|
Adverse Events
Letrozole
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Letrozole
n=4 participants at risk
Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks.
Letrozole: 2.5 mg Tablet By Mouth Daily for 12 Weeks.
|
Standard of Care
n=5 participants at risk
Patients receive no treatment. Follow up every 3 months.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Metabolism and nutrition disorders
Bilirubin
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Metabolism and nutrition disorders
Cholesterol
|
50.0%
2/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
75.0%
3/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
General disorders
Fever w/o neutropenia
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Endocrine disorders
Hot Flashes
|
100.0%
4/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
General disorders
Insomnia
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Psychiatric disorders
Memory Impairment
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Psychiatric disorders
Mood Alteration (depression)
|
50.0%
2/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Musculoskeletal and connective tissue disorders
Neuropathy: sensory
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Musculoskeletal and connective tissue disorders
Pain (joint)
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Musculoskeletal and connective tissue disorders
Pain (muscle)
|
50.0%
2/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itching
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
25.0%
1/4 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
0.00%
0/5 • From study entry to time of progression or death
5 Participants was under observation and received no treatments
|
Additional Information
Coleman,Robert,M.D. / Gyn Onc & Reproductive Medicine
UT MD Anderson Cancer Center
Phone: 7137923203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place