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

NCT01061606 | Terminated Phase 2 Results DMC

• 4 other identifiers: NCI-2012-029898167N01CM00038P30CA013330
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 20

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.

Conditions

Recurrent Uterine Sarcoma; Uterine Carcinosarcoma

Outcome Measures

Primary Outcomes (2)

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

  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.

  6 months from registration

Secondary Outcomes (4)

• Overall Survival

  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

  Up to 3 years

• Time to Treatment Failure

  From study registration to the date patients end treatment, assessed up to 3 years

• Time to Progression

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

Study Arms (1)

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.

Drug: temsirolimus

Interventions

temsirolimus DRUG

Given IV

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

Treatment (temsirolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (20)

Tower Cancer Research Foundation

Beverly Hills, California, 90211-1850, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

City of Hope Medical Group Inc

Pasadena, California, 91105, United States

Location

University of California at Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

The Valley Hospital-Luckow Pavilion

Paramus, New Jersey, 07652, United States

Location

Women's Cancer Care Associates LLC

Albany, New York, 12208, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Saint Luke's Roosevelt Hospital Center - Roosevelt Division

New York, New York, 10019, United States

Location

Presbyterian-Weill Medical College

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Children's Hospital of New York Presbyterian

New York, New York, 10032, United States

Location

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

temsirolimus; Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Lisa Escobar-Peralta, Program Manager
• Organization: Montefiore Medical Center

lescobar@montefiore.org

718-379-6866

Study Officials

• Mark Einstein

  Montefiore Medical Center - Moses Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 9, 2016
• Results First Posted: November 9, 2016

Record last verified: 2016-09

Locations

US (20)