Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:April 30, 2007

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A Phase 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma

This phase II trial studies how well sunitinib malate works in treating patients with
endometrial cancer that has come back after a period of improvement (recurrent) or has spread
to other places in the body (metastatic). Sunitinib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PRIMARY OBJECTIVES:

I. To assess the objective response rate of recurrent or metastatic endometrial cancer to
sunitinib (sunitinib malate).

II. To assess the frequency of prolonged stable disease (as defined by percentage [%] of
patients alive and free from progressive disease at 6 months) in patients with recurrent or
metastatic endometrial cancer treated with sunitinib.

SECONDARY OBJECTIVES:

I. To assess time-to- progression, median overall survival, and rate of one-year survival in
patients with recurrent or metastatic endometrial cancer treated with sunitinib.

II. To assess the toxicity associated with sunitinib in patients with recurrent or metastatic
endometrial cancer.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat
every 6 weeks in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed up at 4 weeks and then every 3
months until relapse.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed endometrial cancer;
adenocarcinoma (endometrioid and serous/papillary serous) and carcinosarcoma (ie.
malignant mixed Mullerian tumor [MMMT]) of the uterus will be investigated; patients
with other histologies (eg. squamous cell carcinoma or leiomyosarcoma) are excluded

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT)
scan; indicator lesions must not have been previously treated with surgery,
radiotherapy, or radiofrequency ablation

- Previously treated patients must have evidence of progressive disease, either
clinically or radiographically, as assessed by the investigator

- Eligible patients may have received no more than one prior cytotoxic chemotherapy
regimen for recurrent, locally-advanced, or metastatic disease; if the prior
chemotherapy was an anthracycline, they may have received no more than 6 cycles (or
less than 450 mg/m^2 doxorubicin); patients must have completed any previous
chemotherapy a minimum of 4 weeks (or 6 weeks if the regimen contained carmustine
[BCNU] or mitomycin) prior to study registration; prior investigational treatment is
permissible (as long as such treatment completed 4 weeks prior to registration)

- Life expectancy of greater than 3 months

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60)

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count (ANC) >= 1,500/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 100 g/dL

- Serum calcium =< 12.0 mg/dL (=< 3.0 mmol/L)

- Total serum bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X
institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Serum lipase =< 1.5 x institutional upper limit of normal

- Serum amylase =< 1.5 x institutional upper limit of normal

- Thyroid stimulating hormone (TSH)/T3/T4 within normal institutional limits

- Magnesium >= 0.5 mmol/L

- Patients must have corrected QT interval (QTc) < 500 msec

- The following group of patients are eligible provided they have normal baseline
cardiac function (as determined by estimate of left ventricular ejection fraction
[LVEF] on echocardiogram or multi-gated acquisition scan [MUGA]):

- Those with a history of congestive heart failure, provided they are no greater
than New York Heart Association (NYHA) class I and on treatment at baseline

- Those with prior anthracycline exposure

- Those who have received prior central thoracic radiation that included the heart
in the radiotherapy port

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; all women of childbearing potential must have a
negative pregnancy test prior to receiving sunitinib; should a woman become pregnant
or suspect she is pregnant while participating in this study, she should inform her
treating physician immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier; at
least 4 weeks must have elapsed since any major surgery

- Patients may not be receiving any other investigational agents

- Patients who have received prior treatment with any other antiangiogenic agent (e.g.,
bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, vascular endothelial growth factor
[VEGF] Trap, etc.) are ineligible

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sunitinib

- Patients who have a history of serious ventricular arrhythmias (ventricular
tachycardia [VT] or ventricular fibrillation [VF] equal to or greater than 3 beats in
a row), QTc prolongation (defined as a QTc interval equal to or greater than 500 msec)
or other significant electrocardiogram (ECG) abnormalities are excluded

- Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or
higher or diastolic blood pressure of 90 mmHg or higher) are ineligible

- Patients who require use of therapeutic doses of coumarin-derivative anticoagulants
such as warfarin are excluded, although doses of up to 2 mg daily are permitted for
prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided
the patient's prothrombin time (PT) international normalized ratio (INR) is =< 1.5

- Patients with any condition (e.g., gastrointestinal tract disease resulting in an
inability to take oral medication or a requirement for intravenous [IV] alimentation,
prior surgical procedures affecting absorption, or active peptic ulcer disease) that
impairs their ability to swallow and retain sunitinib tablets are excluded

- Patients with any of the following conditions are excluded:

- Serious or non-healing wound, ulcer, or bone fracture

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days of treatment

- Any history of cerebrovascular accident (CVA) or transient ischemic attack within
12 months prior to study entry

- History of myocardial infarction, cardiac arrhythmia, stable/unstable angina,
symptomatic congestive heart failure, or coronary/peripheral artery bypass graft
or stenting within 12 months prior to study entry

- History of pulmonary embolism within the past 12 months

- Class III or IV heart failure as defined by the NYHA functional classification
system

- Pre-existing adrenal insufficiency (primary or secondary)

- The eligibility of patients taking medications that are potent inducers or inhibitors
of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) will be determined
following a review of their case by the Principal Investigator; every effort should be
made to switch patients taking such agents or substances to other medications,
particularly patients who are taking enzyme-inducing anticonvulsant agents

- Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid
function in the normal range with medication are ineligible

- Patients with known brain metastases should be excluded

- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
or active infections or psychiatric illness/social situations that would limit
compliance with study requirements are ineligible

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with sunitinib malate

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible
We found this trial at
22
sites
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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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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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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Beverly Hills, California 90211
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Edmonton, Alberta
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Evanston, Illinois 60201
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Fort Wayne, IN
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Joliet, IL
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Saint Joseph, Michigan 49085
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Saint Louis, Missouri 63141
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615 N Michigan Street
South Bend, Indiana 46601
(574) 647-7370
Northern Indiana Cancer Research Consortium The Northern Indiana Cancer Research Consortium (NICRC) is comprised of...
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South Pasadena, California 91030
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Springfield, Illinois 62701
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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