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Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy

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ClinicalTrials.gov Identifier: NCT01220609
Recruitment Status : Completed
First Posted : October 14, 2010
Results First Posted : November 3, 2015
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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

Condition or disease Intervention/treatment Phase
Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma Drug: Ixabepilone Other: Laboratory Biomarker Analysis Phase 2

Detailed Description:

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:

Patients receive ixabepilone intravenously (IV) over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Study Start Date : November 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ixabepilone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Ixabepilone
Given IV
Other Names:
  • BMS 247550
  • BMS-247550
Other: Laboratory Biomarker Analysis
Correlative studies



Primary Outcome Measures :
  1. Tumor Response [ Time Frame: Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years. ]
    Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

  2. Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 [ Time Frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment ]

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. ]
    Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

  2. Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years of follow-up. ]
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220609


  Hide Study Locations
Locations
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
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 Gynecologic Oncology
Fort Myers, Florida, United States, 33905
United States, Georgia
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453-2699
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
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 and Medical Center
Dearborn, Michigan, United States, 48124
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
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
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
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
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, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
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
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Linda Duska NRG Oncology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01220609     History of Changes
Other Study ID Numbers: NCI-2011-02656
NCI-2011-02656 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000686644
GOG-0131H ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2010    Key Record Dates
Results First Posted: November 3, 2015
Last Update Posted: November 22, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Leiomyosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents