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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Uterine Sarcoma Uterine Carcinosarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

temsirolimus

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

temsirolimus

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CCI-779 cell cycle inhibitor 779 Torisel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Einstein

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center - Moses Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Los Angeles County-USC Medical Center

Los Angeles, California, United States

Site Status

City of Hope Medical Group Inc

Pasadena, California, United States

Site Status

University of California at Davis Cancer Center

Sacramento, California, United States

Site Status

University of Connecticut

Farmington, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

The Valley Hospital-Luckow Pavilion

Paramus, New Jersey, United States

Site Status