A Phase 2 interventional study of temsirolimus in Recurrent Uterine Sarcoma and Uterine Carcinosarcoma, sponsored by National Cancer Institute (NCI). Terminated at 20 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-09.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial is studying how well temsirolimus works in treating patients with recurrent or persistent cancer of the uterus. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Assess the efficacy of Temsirolimus in women with recurrent or persistent (after primary therapy) Carcinosarcoma (MMMT) of the uterus.
II. Assess the safety and tolerability of Temsirolimus in this patient population.
III. Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival (PFS), 6 month PFS rate, and duration of response.
SECONDARY OBJECTIVES:
I. Overall survival II.Duration of Response III. Time to progression IV. Time to treatment failure
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up periodically for up to 3 years.
75 studies on the registry are indexed under Carcinosarcoma; 10 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 64 interventional studies indexed under Carcinosarcoma.
Browse Carcinosarcoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Triglycerides ≤ 1.5 x ULN
Full-dose anticoagulants, if a patient is receiving full-dose anticoagulants, the following criteria should be met for enrollment:
Exclusion Criteria:
Untreated central nervous system (CNS) metastases; exceptions: patients with known CNS metastases can be enrolled if the brain metastases have been adequately treated and there is no evidence of progression or hemorrhage after treatment as ascertained by clinical examination and brain imaging (MRI or CT) ≤ 12 weeks prior to registration and no ongoing requirement for steroids
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: temsirolimus
Given IV
Also known as: CCI-779, cell cycle inhibitor 779, Torisel
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
Time frame: Up to 3 years
Progression Free Survival
The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.
Time frame: 6 months from registration
Overall Survival
Time to event distributions will be estimated using the Kaplan-Meier method.
Time frame: From registration to death, assessed up to 3 years
Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient's Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented
Median duration of response and the confidence interval for the median duration will be computed.
Time frame: Up to 3 years
Time to Treatment Failure
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
Time frame: From study registration to the date patients end treatment, assessed up to 3 years
Time to Progression
Time frame: Time to progression is defined as the time from registration to disease progression.
A total of 8 patients were enrolled at two institutions between July 2010 and January 2012
| Milestone | Treatment (Temsirolimus) |
|---|---|
| Started | 8 |
| Completed | 0 |
| Not completed | 8 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 1 |
| Withdrew: Disease progression | 4 |
| Withdrew: Alternative therapy | 2 |
| participants | Treatment (Temsirolimus) |
|---|---|
| Disease progression | 4 |
| Stable disease | 2 |
The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.
No measurements were reported for this outcome.
Time to event distributions will be estimated using the Kaplan-Meier method.
No measurements were reported for this outcome.
Median duration of response and the confidence interval for the median duration will be computed.
No measurements were reported for this outcome.
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Temsirolimus) | — | 5/8 (62.5%) | 8/8 (100%) |
| Event | Treatment (Temsirolimus) |
|---|---|
| Abdominal painGastrointestinal disorders | 3/8 |
| ConstipationGastrointestinal disorders | 2/8 |
| NauseaGastrointestinal disorders | 2/8 |
| AscitesGastrointestinal disorders | 1/8 |
| Urinary Tract infectionInfections and infestations | 1/8 |
| Death NOSGeneral disorders | 1/8 |
| VomitingGastrointestinal disorders | 1/8 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/8 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/8 |
| FatigueGeneral disorders | 1/8 |
| Event | Treatment (Temsirolimus) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 3/8 |
| DiarrheaGastrointestinal disorders | 3/8 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/8 |
| DysgeusiaNervous system disorders | 2/8 |
| AnorexiaGastrointestinal disorders | 2/8 |
| PruritisSkin and subcutaneous tissue disorders | 2/8 |
| InsomniaPsychiatric disorders | 2/8 |
| ChillsGeneral disorders | 2/8 |
| HyperglycemiaMetabolism and nutrition disorders | 2/8 |
| HypertensionVascular disorders | 2/8 |
| Age, Continuous(years) | Treatment (Temsirolimus) |
|---|---|
| Median | 62 (47 to 72) |
| Sex: Female, Male(Participants) | Treatment (Temsirolimus) |
|---|---|
| Female | 8 |
| Male | 0 |
| Race/Ethnicity, Customized(participants) | Treatment (Temsirolimus) |
|---|---|
| White | 3 |
| Black | 2 |
| Unknown | 3 |
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)