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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Recurrent Uterine Sarcoma, Uterine Carcinosarcoma

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Trial Information

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


PRIMARY OBJECTIVES:

I. To determine the response rate of patients with persistent or recurrent carcinosarcoma of
the uterus treated with ixabepilone.

II. To determine the nature and degree of toxicity of this regimen in these patients.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival of patients
treated with this regimen.

TERTIARY OBJECTIVES:

I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.

II. To explore the association between class III beta-tubulin expression with response,
progression-free survival, and overall survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity.

Tumor tissue samples from prior surgery may be collected for class III beta-tubulin 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 carcinosarcoma

- Persistent or recurrent disease refractory to curative or established treatments

- Malignant mixed müllerian tumor

- Homologous or heterologous type

- Progressive disease after local therapy

- 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

- Patient 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 after completion of radiotherapy

- Patient must have had 1 prior chemotherapeutic regimen for management of
carcinosarcoma that may have included chemotherapy, chemotherapy and radiotherapy,
and/or consolidation/maintenance therapy

- Chemotherapy administered in conjunction with primary radiation as a
radio-sensitizer is counted as a systemic chemotherapy regimen

- Patients who have not received a prior taxane therapy (e.g., paclitaxel or
docetaxel) must receive a second regimen that includes a taxane

- Patients must not be eligible for a higher priority GOG or Rare Tumor protocol, if
one exists

- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

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

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Peripheral neuropathy (sensory and motor) ≤ grade 1

- No active infection requiring antibiotics except uncomplicated urinary tract
infection

- No history of severe grade 3-4 hypersensitivity reaction to agents containing
Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)

- More than 3 years since other invasive malignancy except non-melanoma skin cancer

- No concurrent amifostine or other protective reagents

- Recovered from recent surgery, radiotherapy, or chemotherapy

- At least 1 week since prior hormonal therapy

- At least 3 weeks since any prior therapy directed at the malignant tumor, including
biological and immunological agents

- One prior non-cytotoxic (biologic or cytostatic) regimen for management of recurrent
or persistent disease that includes, but is not limited to, any of the following
allowed:

- Monoclonal antibodies

- Cytokines

- Small-molecule inhibitors of signal transduction

- More than 3 years since prior radiotherapy to any portion of the abdominal cavity or
pelvis other than for uterine carcinosarcoma

- Prior radiation for localized cancer of the breast, head and neck, or skin
allowed provided the patient remains free of recurrent or metastatic disease

- No prior chemotherapy for any abdominal or pelvic tumor, other than for uterine
carcinosarcoma, within the past 3 years

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer
allowed provided patient has remained free of recurrent or metastatic disease

- No prior ixabepilone

- No prior cancer therapy that contraindicates study treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Frequency of patients with objective tumor response

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Carolyn McCourt

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02056

NCT ID:

NCT01168232

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Uterine Carcinosarcoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Uterine Neoplasms
  • Sarcoma

Name

Location

Cleveland Clinic Foundation Cleveland, Ohio  44195
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Abington Memorial Hospital Abington, Pennsylvania  19001
Hurley Medical Center Flint, Michigan  48503
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Genesys Hurley Cancer Institute Flint, Michigan  48503
Avera Cancer Institute Sioux Falls, South Dakota  57105
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
John Muir Medical Center Walnut Creek, California  94598
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Duke University Medical Center Durham, North Carolina  27710
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Case Western Reserve University Cleveland, Ohio  44106
Riverside Methodist Hospital Columbus, Ohio  43214
Indiana University Medical Center Indianapolis, Indiana  46202
Virginia Commonwealth University Richmond, Virginia  
Florida Hospital Orlando, Florida  32803
Memorial Health University Medical Center Savannah, Georgia  31404
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio  44124
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
The Hospital of Central Connecticut New Britain, Connecticut  06050
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
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
Cancer Care Associates-Yale Tulsa, Oklahoma  74136-1929
Women and Infants Hospital Providence, Rhode Island  02905
Lake University Ireland Cancer Center Mentor, Ohio  44060
Stony Brook University Medical Center Stony Brook, New York  11794
John Muir Medical Center-Concord Campus Concord, California  94520
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
State University of New York Downstate Medical Center Brooklyn, New York  11203
Women's Cancer Center of Nevada Las Vegas, Nevada  89109
Sudarshan K Sharma MD Limted-Gynecologic Oncology Hinsdale, Illinois  60521
Saint Vincent Oncology Center Indianapolis, Indiana  46260
Methodist West Hospital West Des Moines, Iowa  50266-7700
Summa Akron City Hospital Akron, Ohio  44304
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio  44111
Mercy Cancer Center-West Lakes Clive, Iowa  50325
Mercy Medical Center-West Lakes West Des Moines, Iowa  50266