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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:January 2010

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Pilot Phase II Study of Temsirolimus in Patients With Recurrent Mixed Mesodermal and Mullerian Tumors (Carcinosarcoma) of the Uterus."


RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.

PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients
with recurrent or persistent cancer of the uterus.


OBJECTIVES:

- Assess the efficacy of temsirolimus in patients with recurrent or persistent malignant
mixed mesodermal and Mullerian tumors (carcinosarcoma) of the uterus.

- Assess the safety and tolerability of this drug in these patients.

- Evaluate the time to tumor progression in patients treated with this drug.

- Evaluate the progression-free survival (PFS) of patients treated with this drug.

- Evaluate the 6-month PFS rate in patients treated with this drug.

- Evaluate the duration of response in patients treated with this drug.

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.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed malignant mixed mesodermal and Mullerian
tumors (MMMT) (carcinosarcoma) of the uterus

- Recurrent or persistent disease after primary adjuvant therapy

- Measurable disease

- Patients with lesions measuring ≥ 1 cm to < 2 cm must undergo spiral CT imaging
for both pre- and post-treatment tumor assessments

- Patients who have had prior palliative radiotherapy to metastatic lesion(s) must
have ≥ 1 measurable lesion(s) that has not been previously irradiated

- Tissue samples or blocks from primary tumor or metastases available for tumor studies

- No untreated CNS metastases

- Adequately treated brain metastases allowed provided the following criteria are
met:

- No evidence of progression or hemorrhage after treatment as ascertained by
clinical examination and brain imaging (MRI or CT scan) within the past 12
weeks

- No ongoing requirement for steroids

- Stable dose of anticonvulsants allowed

- No surgical resection of CNS metastases or brain biopsy within the past 3
months

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- Direct bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)

- AST ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)

- Creatinine ≤ 1.5 times ULN

- Fasting serum cholesterol ≤ 350 mg/dL (9.0 mmol/L)

- Triglycerides ≤ 1.5 times ULN (lipid lowering agents allowed)

- INR ≤ 1.5 (unless on full-dose warfarin)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study therapy

- LVEF normal by MUGA or ECHO within the past 4 weeks (for patients who have had prior
anthracycline)

- Willing to donate blood for correlative studies

- No currently active second malignancy other than nonmelanoma skin cancer

- No other uncontrolled serious medical or psychiatric condition (e.g., cardiac
arrhythmias or diabetes)

- No active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 1 prior systemic treatment after primary adjuvant therapy for persistent
or metastatic disease, including any of the following:

- Targeted therapies

- Biologic response modifiers

- Chemotherapy

- Hormonal therapy

- Investigational therapy

- At least 1 week since prior hormonal therapy

- At least 3 weeks since all other prior therapies

- At least 4 weeks since prior adjuvant or palliative radiotherapy

- No prior radiotherapy to any portion of the abdominal cavity or pelvis other than for
the treatment of endometrial cancer

- No prior radiotherapy to > 50% of marrow-bearing areas

- No prior temsirolimus or another mTOR inhibitor

- No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or
phenobarbital) or any other CYP3A4 inducer (e.g., rifampin or St. John wort)

- No concurrent radiotherapy

- Concurrent full-dose anticoagulants allowed provided INR is in range (2-3) AND
patient is on a stable dose of warfarin or low molecular weight heparin

- Concurrent zoledronic acid for bone metastases and/or hypercalcemia allowed provided
it was started before initiation of study treatment
We found this trial at
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Beverly Hills, California 90211
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1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
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701 West 168th Street
New York, New York 10032
(212) 851-4680
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center The Herbert Irving Comprehensive Cancer...
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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Albany, New York 12208
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Los Angeles, California 90033
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100 Madison Avenue
Morristown, New Jersey 07960
973-971-6100
Carol G. Simon Cancer Center at Morristown Memorial Hospital Located in northern New Jersey, we...
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160 E 34th St
New York, New York 10016
(212) 731-5001
NYU Cancer Institute at New York University Medical Center The Perlmutter Cancer Center takes a...
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Pasadena, California 91105
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