CClinicalTrials.gg
TerminatedNCT01061606Updated Nov 9, 2016Results posted

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

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

Why this study was terminated
Poor accrual
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Recurrent Uterine Sarcoma
  • Uterine Carcinosarcoma
03

In context

Carcinosarcoma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Treatment (temsirolimus)

    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

Interventions

  • Drugtemsirolimus

    Given IV

    Also known as: CCI-779, cell cycle inhibitor 779, Torisel

06

What researchers measure

Primary outcomes

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

    Time frame: Up to 3 years

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Time to Progression

    Time frame: Time to progression is defined as the time from registration to disease progression.

07

Results

Posted Nov 9, 2016

Participant flow

A total of 8 patients were enrolled at two institutions between July 2010 and January 2012

Participant flow — Overall Study
MilestoneTreatment (Temsirolimus)
Started8
Completed0
Not completed8
Withdrew: Adverse event1
Withdrew: Death1
Withdrew: Disease progression4
Withdrew: Alternative therapy2

Outcome measures

PrimaryTumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
Time frame:
Up to 3 years
Reported as:
Number · participants
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
participantsTreatment (Temsirolimus)
Disease progression4
Stable disease2
PrimaryProgression 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

No measurements were reported for this outcome.

SecondaryOverall Survival

Time to event distributions will be estimated using the Kaplan-Meier method.

Time frame:
From registration to death, assessed up to 3 years

No measurements were reported for this outcome.

SecondaryDuration 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

No measurements were reported for this outcome.

SecondaryTime 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

No measurements were reported for this outcome.

SecondaryTime to Progression
Time frame:
Time to progression is defined as the time from registration to disease progression.

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Temsirolimus)—5/8 (62.5%)8/8 (100%)
Most frequent serious events
Most frequent serious events
EventTreatment (Temsirolimus)
Abdominal painGastrointestinal disorders3/8
ConstipationGastrointestinal disorders2/8
NauseaGastrointestinal disorders2/8
AscitesGastrointestinal disorders1/8
Urinary Tract infectionInfections and infestations1/8
Death NOSGeneral disorders1/8
VomitingGastrointestinal disorders1/8
Pleural effusionRespiratory, thoracic and mediastinal disorders1/8
DyspneaRespiratory, thoracic and mediastinal disorders1/8
FatigueGeneral disorders1/8
Most frequent other events
Showing 10 of 40
Most frequent other events
EventTreatment (Temsirolimus)
AnemiaBlood and lymphatic system disorders3/8
DiarrheaGastrointestinal disorders3/8
MyalgiaMusculoskeletal and connective tissue disorders2/8
DysgeusiaNervous system disorders2/8
AnorexiaGastrointestinal disorders2/8
PruritisSkin and subcutaneous tissue disorders2/8
InsomniaPsychiatric disorders2/8
ChillsGeneral disorders2/8
HyperglycemiaMetabolism and nutrition disorders2/8
HypertensionVascular disorders2/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Temsirolimus)
Median62 (47 to 72)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Temsirolimus)
Female8
Male0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Treatment (Temsirolimus)
White3
Black2
Unknown3
08

Study locations

20 sites
  • Tower Cancer Research Foundation
    Beverly Hills, California 90211-1850, United States
  • City of Hope
    Duarte, California 91010, United States
  • Los Angeles County-USC Medical Center
    Los Angeles, California 90033, United States
  • City of Hope Medical Group Inc
    Pasadena, California 91105, United States
  • University of California at Davis Cancer Center
    Sacramento, California 95817, United States
  • University of Connecticut
    Farmington, Connecticut 06030, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Morristown Memorial Hospital
    Morristown, New Jersey 07962, United States
  • The Valley Hospital-Luckow Pavilion
    Paramus, New Jersey 07652, United States
  • Women's Cancer Care Associates LLC
    Albany, New York 12208, United States
  • Montefiore Medical Center - Moses Campus
    Bronx, New York 10467-2490, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • New York University Langone Medical Center
    New York, New York 10016, United States
  • Saint Luke's Roosevelt Hospital Center - Roosevelt Division
    New York, New York 10019, United States
  • Presbyterian-Weill Medical College
    New York, New York 10021, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • Children's Hospital of New York Presbyterian
    New York, New York 10032, United States
  • Columbia University College of Physicians and Surgeons
    New York, New York 10032, United States
  • Penn State Hershey Children's Hospital
    Hershey, Pennsylvania 17033, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01061606
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 3, 2010
Start date
Jan 2010
Primary completion
Apr 2012
Completion
Oct 2012
Results posted
Nov 9, 2016
Last update
Nov 9, 2016

Study contacts

Mark Einstein
principal investigator · Montefiore Medical Center - Moses Campus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion