Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

This study is currently recruiting participants.
Verified September 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01168232
First received: July 22, 2010
Last updated: September 4, 2013
Last verified: September 2013
  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 (IND #59699, 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.


Estimated Enrollment: 37
Study Start Date: September 2010
Estimated Primary Completion Date: February 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168232

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences Completed
Little Rock, Arkansas, United States, 72205
United States, California
John Muir Medical Center-Concord Campus Completed
Concord, California, United States, 94520
John Muir Medical Center Completed
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Susan A. Davidson    720-848-0650      
Principal Investigator: Susan A. Davidson         
United States, Connecticut
Hartford Hospital Completed
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center Completed
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut Completed
New Britain, Connecticut, United States, 06050
United States, Florida
Florida Hospital Completed
Orlando, Florida, United States, 32803
United States, Georgia
Memorial Health University Medical Center Completed
Savannah, Georgia, United States, 31403
United States, Idaho
Saint Alphonsus Regional Medical Center Completed
Boise, Idaho, United States, 83706
United States, Illinois
Rush University Medical Center Completed
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center Completed
Chicago, Illinois, United States, 60637-1470
Sudarshan K Sharma MD Limted-Gynecologic Oncology Completed
Hinsdale, Illinois, United States, 60521
Good Samaritan Regional Medical Center Completed
Mt. Vernon, Illinois, United States, 62864
Central DuPage Hospital Cancer Center Completed
Warrenville, Illinois, United States, 60555
United States, Indiana
Indiana University Medical Center Completed
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center Completed
Indianapolis, Indiana, United States, 46260
United States, Iowa
Mercy Cancer Center-West Lakes Completed
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-West Des Moines Completed
Clive, Iowa, United States, 50325
Iowa Oncology Research Association CCOP Completed
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital Completed
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center Completed
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates Completed
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates-Des Moines Completed
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines Completed
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics Completed
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes Completed
West Des Moines, Iowa, United States, 50266
Methodist West Hospital Completed
West Des Moines, Iowa, United States, 50266-7700
United States, Maryland
Sinai Hospital of Baltimore Completed
Baltimore, Maryland, United States, 21215
United States, Michigan
Saint Joseph Mercy Hospital Completed
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program Completed
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital Completed
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center Completed
Detroit, Michigan, United States, 48236
Genesys Regional Medical Center-West Flint Campus Recruiting
Flint, Michigan, United States, 48532
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Genesys Hurley Cancer Institute Completed
Flint, Michigan, United States, 48503
Hurley Medical Center Completed
Flint, Michigan, United States, 48502
Genesys Regional Medical Center Completed
Grand Blanc, Michigan, United States, 48439
Allegiance Health Completed
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital Completed
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center Completed
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center Completed
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital Completed
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital Completed
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland Completed
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron Completed
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan Completed
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital Completed
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Medical Center Completed
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint John's Regional Medical Center Completed
Joplin, Missouri, United States, 64804
Saint John's Clinic-Rolla-Cancer and Hematology Completed
Rolla, Missouri, United States, 65401
Washington University School of Medicine Completed
Saint Louis, Missouri, United States, 63110
Saint John's Mercy Medical Center Completed
Saint Louis, Missouri, United States, 63141
Saint Louis Cancer and Breast Institute-South City Completed
Saint Louis, Missouri, United States, 63109
Saint John's Hospital Completed
Springfield, Missouri, United States, 65804
Cox Medical Center Completed
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Completed
Springfield, Missouri, United States, 65802
United States, Nebraska
Nebraska Methodist Hospital Completed
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada Completed
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Cooper Hospital University Medical Center Completed
Camden, New Jersey, United States, 08103
United States, New York
State University of New York Downstate Medical Center Completed
Brooklyn, New York, United States, 11203
Stony Brook University Medical Center Completed
Stony Brook, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center Completed
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
United States, Ohio
Summa Akron City Hospital Completed
Akron, Ohio, United States, 44304
Case Western Reserve University Completed
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Completed
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital Completed
Cleveland, Ohio, United States, 44111
Riverside Methodist Hospital Completed
Columbus, Ohio, United States, 43214
Hillcrest Hospital Cancer Center Completed
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center Completed
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center Completed
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates-Yale Completed
Tulsa, Oklahoma, United States, 74136-1929
United States, Pennsylvania
Abington Memorial Hospital Completed
Abington, Pennsylvania, United States, 19001
United States, Rhode Island
Women and Infants Hospital Completed
Providence, Rhode Island, United States, 02905
United States, South Dakota
Avera Cancer Institute Completed
Sioux Falls, South Dakota, United States, 57105
United States, Virginia
Virginia Commonwealth University Withdrawn
Richmond, Virginia, United States, 23298
United States, Wisconsin
University of Wisconsin Hospital and Clinics Completed
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: September 4, 2013
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 April 22, 2014