Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01168232
First received: July 22, 2010
Last updated: June 10, 2014
Last verified: May 2014
  Purpose

This phase II trial is studying the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.


Condition Intervention Phase
Recurrent Uterine Sarcoma
Uterine Carcinosarcoma
Drug: ixabepilone
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency of patients with objective tumor response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier product limit estimates will be provided along with descriptive measures such as their median estimates.

  • Duration of overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier product limit estimates will be provided along with descriptive measures such as their median estimates.


Enrollment: 33
Study Start Date: September 2010
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168232

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
John Muir Medical Center
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Allegiance Health
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Mercy Hospital-Joplin
Joplin, Missouri, United States, 64804
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65802
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Investigators
Principal Investigator: Carolyn McCourt Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01168232     History of Changes
Other Study ID Numbers: NCI-2011-02056, NCI-2011-02056, GOG-0130F, CDR0000681684, GOG-0130F, GOG-0130F, U10CA027469
Study First Received: July 22, 2010
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinosarcoma
Mixed Tumor, Mullerian
Uterine Neoplasms
Sarcoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Epothilone B
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014