Know Cancer

forgot password

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
Not Enrolling
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


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.


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

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

- 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

- 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:


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:


Principal Investigator

Linda Duska

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Uterine Leiomyosarcoma
  • Leiomyosarcoma
  • Sarcoma



Cleveland Clinic Foundation Cleveland, Ohio  44195
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Washington University School of Medicine Saint Louis, Missouri  63110
Abington Memorial Hospital Abington, Pennsylvania  19001
Hurley Medical Center Flint, Michigan  48503
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Avera Cancer Institute Sioux Falls, South Dakota  57105
Henry Ford Hospital Detroit, Michigan  48202
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
Rush University Medical Center Chicago, Illinois  60612-3824
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Hartford Hospital Hartford, Connecticut  06102-5037
Carolinas Medical Center Charlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Advocate Christ Medical Center Oak Lawn, Illinois  60453
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Geisinger Medical Group State College, Pennsylvania  16801
Singing River Hospital Pascagoula, Mississippi  39581
Greater Baltimore Medical Center Baltimore, Maryland  21204
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Phelps County Regional Medical Center Rolla, Missouri  65401
University of Virginia Charlottesville, Virginia  22908
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Case Western Reserve University Cleveland, Ohio  44106
Riverside Methodist Hospital Columbus, Ohio  43214
Florida Gynecologic Oncology Fort Myers, Florida  33901
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio  44124
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
University of Southern California Los Angeles, California  90033
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
The Hospital of Central Connecticut New Britain, Connecticut  06050
John B Amos Cancer Center Columbus, Georgia  31904
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Saint John's Hospital Springfield, Missouri  65804
Cox Medical Center Springfield, Missouri  65807
Cooper Hospital University Medical Center Camden, New Jersey  08103
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Greenville CCOP Greenville, South Carolina  29615
Oconomowoc Memorial Hospital-ProHealth Care Inc Oconomowoc, Wisconsin  53066-3896
Cancer Care Associates-Yale Tulsa, Oklahoma  74136-1929
Women and Infants Hospital Providence, Rhode Island  02905
Lake University Ireland Cancer Center Mentor, Ohio  44060
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
Cancer Centers of the Carolinas - Faris Greenville, South Carolina  29605
Women's Cancer Center of Nevada Las Vegas, Nevada  89109
Central DuPage Hospital Cancer Center Warrenville, Illinois  60555
Saint John's Clinic-Rolla-Cancer and Hematology Rolla, Missouri  65401
Los Angeles County-USC Medical Center Los Angeles, California  90033
Gynecologic Oncology Group of Arizona Phoenix, Arizona  85012
Sudarshan K Sharma MD Limted-Gynecologic Oncology Hinsdale, Illinois  60521
Saint Vincent Oncology Center Indianapolis, Indiana  46260
Summa Akron City Hospital Akron, Ohio  44304
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio  44111
D N Greenwald Center Mukwonago, Wisconsin  53149