Recurrent Uterine SarcomaPhase 2NCT01061606
Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
A Phase 2 study testing temsirolimus in people with Recurrent Uterine Sarcoma and Uterine Carcinosarcoma, run by National Cancer Institute (NCI) at 20 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Uterine Sarcoma, Uterine Carcinosarcoma
- What is being tested?
- temsirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 20 sitesUnited States
- Study dates
- Jan 2010to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Women's Cancer Care Associates LLC
Albany, New York, 12208
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850
City of Hope
Duarte, California, 91010
University of Connecticut
Farmington, Connecticut, 06030
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
Morristown Memorial Hospital
Morristown, New Jersey, 07962
Yale University
New Haven, Connecticut, 06520
Beth Israel Medical Center
New York, New York, 10003
New York University Langone Medical Center
New York, New York, 10016
Saint Luke's Roosevelt Hospital Center - Roosevelt Division
New York, New York, 10019
Presbyterian-Weill Medical College
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Children's Hospital of New York Presbyterian
New York, New York, 10032
Columbia University College of Physicians and Surgeons
New York, New York, 10032
The Valley Hospital-Luckow Pavilion
Paramus, New Jersey, 07652
City of Hope Medical Group Inc
Pasadena, California, 91105
University of California at Davis Cancer Center
Sacramento, California, 95817
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490
About this study
Official title: Pilot Phase II Study of Temsirolimus in Patients With Recurrent Mixed Mesodermal and Mullerian Tumors (Carcinosarcoma) of the Uterus
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:
- 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:
- 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.
- Conditions
- Recurrent Uterine Sarcoma, Uterine Carcinosarcoma
- Being tested
- temsirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temsirolimusDrug
Also called CCI-779, cell cycle inhibitor 779, Torisel
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (temsirolimus) | Experimental | 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. Receives: Drug: temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
Measured: 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.
Measured: 6 months from registration
Secondary outcomes (4)
Overall Survival
Time to event distributions will be estimated using the Kaplan-Meier method.
Measured: 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.
Measured: Up to 3 years
Time to Treatment Failure
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
Measured: From study registration to the date patients end treatment, assessed up to 3 years
Time to Progression
Measured: Time to progression is defined as the time from registration to disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionOct 2012
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Uterine SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Einstein, Principal investigator, Montefiore Medical Center - Moses Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061606
- Sponsor's protocol ID
- NCI-2012-02989
- Other IDs
- NCI-2012-02989, 8167, N01CM00038, P30CA013330
- Status last verified
- Sep 2016
- First submitted
- 2 Feb 2010
- Last updated
- 9 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase II Study of Temsirolimus in Patients With Recurrent Mixed Mesodermal and Mullerian Tumors (Carcinosarcoma) of the Uterus
- ClinicalTrials.gov ID
- NCT01061606
- Acronym / sponsor ID
- NCI-2012-02989
- Conditions
- Recurrent Uterine Sarcoma, Uterine Carcinosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Posted 9 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (temsirolimus) | Experimental | Drug: temsirolimusPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temsirolimusAlso: CCI-779, cell cycle inhibitor 779, ToriselGiven IV | Drug | Treatment (temsirolimus) |
Primary outcome
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
Time frame: 6 months from registration
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.
4 secondary outcomes
Overall Survival
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
Time frame: Up to 3 years
Time to Treatment Failure
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Einstein principal investigator
Montefiore Medical Center - Moses Campus
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temsirolimus in people with Recurrent Uterine Sarcoma and Uterine Carcinosarcoma, run by National Cancer Institute (NCI) at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.