NCT01061606 · REGISTRY CONDITION SEARCH

Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2016-11-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

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

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outcome · POSTED

Time to Treatment Failure

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outcome · POSTED

Time to Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed Carcinosarcoma (MMMT) * Measurable disease; * Only one prior systemic treatments after primary adjuvant treatment for persistent or metastatic disease are permitted, * Radiation therapy (adjuvant or palliative) must be completed ≥ 4 weeks prior to registration * Required laboratory values obtained =\< 7 days prior to registration: * Absolute Neutrophil Count (ANC) \>= 1500/mm\^3 * Platelets \>= 75,000/mm\^3 * Hemoglobin \>= 9.0 g/dL * Direct bilirubin =\< 1.5 x upper limit of normal (ULN) * Alkaline phosphatase =\< 2.5 x ULN (≤ 5 x ULN if liver metastasis is present) * SGOT(AST) =\< 2.5 x ULN (≤ 5 x ULN if liver metastasis is present) * Creatinine =\< 1.5 x ULN * Fasting serum cholesterol ≤ 350mg/dL (9.0 mmol/L) * Triglycerides ≤ 1.5 x ULN * Patients with Triglyceride levels \> 1.5 x ULN can be started on lipid lowering agents and reevaluated within 1 week; if levels go to ≤ 1.5 x ULN, they can be considered for the trial and continue the lipid lowering agents * International Normalized Ratio (INR) ≤ 1.5 (unless the patient is on full dose warfarin) * ECOG Performance Status (PS) 0-1 * Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent * Full-dose anticoagulants, if a patient is receiving full-dose anticoagulants, the following criteria should be met for enrollment: * The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW heparin * Patients who have had prior anthracycline must have a normal ejection fraction on LVEF assessment by MUGA or Echo ≤ 4 weeks prior to registration * Availability of tissue samples or blocks (from the primary tumor or metastases) for tumor studies * Willingness to donate blood for correlative marker studies Exclusion Criteria: * Prior therapy with Temsirolimus or another mTOR inhibitors * Patients cannot be receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort * 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 * Anticonvulsants (stable dose) are allowed * Patients who had surgical resection of CNS metastases or brain biopsy ≤ 3 months prior to registration will be excluded * Pregnant or lactating wome * Currently active, second malignancy other than non-melanoma skin cancers; - Other uncontrolled serious medical or psychiatric condition (e.g. cardiac arrhythmias, diabetes, etc.) * Active infection requiring antibiotics * Received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer * Radiation therapy to \> 50% of marrow bearing areas
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: temsirolimus
label
Treatment (temsirolimus)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (temsirolimus)
description
Given IV
name
temsirolimus
other Names
CCI-779
cell cycle inhibitor 779
Torisel
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 8
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
time Frame
Up to 3 years
description
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.
measure
Progression Free Survival
time Frame
6 months from registration

secondary Outcomes

description
Time to event distributions will be estimated using the Kaplan-Meier method.
measure
Overall Survival
time Frame
From registration to death, assessed up to 3 years
description
Median duration of response and the confidence interval for the median duration will be computed.
measure
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
time Frame
Up to 3 years
description
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
measure
Time to Treatment Failure
time Frame
From study registration to the date patients end treatment, assessed up to 3 years
measure
Time to Progression
time Frame
Time to progression is defined as the time from registration to disease progression.

Full study description

brief Summary: 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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-a98a715af11a5a2cbb28
requested nct id
NCT01061606
primary nct id
NCT01061606
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
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id
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link basis
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nct id
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occurrences
context exact
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end
11
exact text
NCT01061606
start
0
offset unit
unicode_code_points
query cond
Uterine Sarcoma
query disease state id
ds-uterine-sarcoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
source file sha256
21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
source json pointer
/studies/48/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
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source string basis
parsed_JSON_string_unmodified
source string sha256
cbf59f2b46680b05aa8f14d2e6e2a3cf2e83bb0d9006df38edd63140579d74bc
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice