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A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Uterine Sarcoma, Uterine Leiomyosarcoma

Thank you

Trial Information

A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


PRIMARY OBJECTIVES:

I. To determine the response rate (complete and partial responses by RECIST 1.1) of
ixabepilone in patients with recurrent or persistent leiomyosarcoma of the uterus who have
failed one previous chemotherapy regimen.

II. To determine the nature and degree of toxicity of ixabepilone as assessed by NCI Common
Terminology Criteria for Adverse Events (CTCAE) version 4 in this cohort of patients.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival (PFS) and overall survival (OS).

II. To determine the level of beta-III tubulin expression measured by IHC in women with
leiomyosarcoma.

III. To determine if beta-III tubulin expression as measured by IHC predicts response to
ixabepilone in women with leiomyosarcoma.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity. Tumor tissue samples from prior
surgery may be collected for beta-III tubulin expression analysis by IHC.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.


Inclusion Criteria:



- Histologically confirmed uterine leiomyosarcoma

- Persistent or recurrent disease that is refractory to curative or established
treatments

- Histologic confirmation of the original primary tumor is required

- Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded)

- Each lesion must be ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical
exam OR ≥ 20 mm by chest x-ray

- Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

- Must have ≥ 1 "target lesion" to assess response

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days following completion of radiotherapy

- Not eligible for a higher priority GOG protocol, if one exists

- Must have had 1 prior cytotoxic regimen that included a taxane regimen for management
of leiomyosarcoma

- Single-agent or multi-agent therapy allowed

- Patients who did not receive prior therapy with a taxane (e.g., docetaxel) must
receive a second regimen that includes a taxane

- No known brain metastases

- GOG performance status 0-2

- Life expectancy > 6 months

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- AST ≤ 3 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Peripheral neuropathy (sensory or mother) ≤ grade 1

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception prior to and for the duration of
study participation

- Free of active infection requiring antibiotics

- Uncomplicated urinary tract infection allowed

- No other invasive malignancy except non-melanoma skin cancer or curatively treated
localized cancer of the breast, head and neck, or skin that was completed more than 3
years ago and the patient remains free of recurrence or metastatic disease

- No history of a severe hypersensitivity reaction to agents containing Cremophor EL or
its derivatives (e.g., polyoxyethylated castor oil)

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina

- Cardiac arrhythmia

- Psychiatric illness and/or social situations that would limit compliance with
study requirements

- No concurrent amifostine or other protective agents

- Recovered from effects of recent surgery, radiotherapy, or chemotherapy

- At least 1 week since prior hormonal therapy

- Hormonal therapy (cytotoxic or non-cytotoxic) not counted as prior regimen

- At least 3 weeks since any other prior therapy directed to the malignant tumor,
including immunologic agents

- At least 4 weeks since prior radiation therapy

- One prior non-cytotoxic (biologic or cytostatic) regimen, administered as part of the
previous cytotoxic regimen or in addition to it, allowed

- Non-cytotoxic agents include, but are not limited to, the following:

- Monoclonal antibodies

- Cytokines

- Small-molecule inhibitors of signal transduction

- More than 3 years since radiotherapy for localized cancer of the breast, head and
neck, or skin provided patient remains free of recurrence or metastatic disease

- No prior ixabepilone

- No prior chemotherapy for any abdominal or pelvic tumor other than for the treatment
of uterine leiomyosarcoma within the past 3 years

- Prior chemotherapy for localized breast cancer allowed provided it was completed more
than 3 years ago and patient remains free of recurrent or metastatic disease

- No other concurrent investigational agents

- No concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole,
clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir,
amprenavir, indinavir, nelfinavir, delavirdine, voriconazole, or grapefruit juice) or
CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifampicin,
rifabutin, phenobarbital, or St. John wort)

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response (complete or partial response) as measured by RECIST

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Linda Duska

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02656

NCT ID:

NCT01220609

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Uterine Leiomyosarcoma
  • Leiomyosarcoma
  • Sarcoma

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Abington Memorial HospitalAbington, Pennsylvania  19001
Hurley Medical CenterFlint, Michigan  48503
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Avera Cancer InstituteSioux Falls, South Dakota  57105
Henry Ford HospitalDetroit, Michigan  48202
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Rush University Medical CenterChicago, Illinois  60612-3824
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hartford HospitalHartford, Connecticut  06102-5037
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Advocate Christ Medical CenterOak Lawn, Illinois  60453
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Geisinger Medical GroupState College, Pennsylvania  16801
Singing River HospitalPascagoula, Mississippi  39581
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Phelps County Regional Medical CenterRolla, Missouri  65401
University of VirginiaCharlottesville, Virginia  22908
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Case Western Reserve UniversityCleveland, Ohio  44106
Riverside Methodist HospitalColumbus, Ohio  43214
Florida Gynecologic OncologyFort Myers, Florida  33901
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
University of Southern CaliforniaLos Angeles, California  90033
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
John B Amos Cancer CenterColumbus, Georgia  31904
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Greenville CCOPGreenville, South Carolina  29615
Oconomowoc Memorial Hospital-ProHealth Care IncOconomowoc, Wisconsin  53066-3896
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Women and Infants HospitalProvidence, Rhode Island  02905
Lake University Ireland Cancer CenterMentor, Ohio  44060
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Central DuPage Hospital Cancer CenterWarrenville, Illinois  60555
Saint John's Clinic-Rolla-Cancer and HematologyRolla, Missouri  65401
Los Angeles County-USC Medical CenterLos Angeles, California  90033
Gynecologic Oncology Group of ArizonaPhoenix, Arizona  85012
Sudarshan K Sharma MD Limted-Gynecologic OncologyHinsdale, Illinois  60521
Saint Vincent Oncology CenterIndianapolis, Indiana  46260
Summa Akron City HospitalAkron, Ohio  44304
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Ohio  44111
D N Greenwald CenterMukwonago, Wisconsin  53149