- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168232
Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus.
II. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival.
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 in carcinosarcoma of the uterus and response, progression-free and overall survival.
OUTLINE:
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats 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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Concord, California, United States, 94520
- John Muir Medical Center-Concord Campus
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Walnut Creek, California, United States, 94598
- John Muir Medical Center-Walnut Creek
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
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Connecticut
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Hartford, Connecticut, United States, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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New Britain, Connecticut, United States, 06050
- The Hospital of Central Connecticut
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Florida
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Orlando, Florida, United States, 32803
- Florida Hospital Orlando
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Georgia
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Savannah, Georgia, United States, 31404
- Memorial University Medical Center
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
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Hinsdale, Illinois, United States, 60521
- Sudarshan K Sharma MD Limted-Gynecologic Oncology
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Mount Vernon, Illinois, United States, 62864
- Good Samaritan Regional Health Center
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Warrenville, Illinois, United States, 60555
- Northwestern Medicine Cancer Center Warrenville
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States, 46260
- Saint Vincent Hospital and Health Care Center
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Iowa
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Clive, Iowa, United States, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, United States, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, United States, 50309
- Iowa-Wide Oncology Research Coalition NCORP
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Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates-Laurel
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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West Des Moines, Iowa, United States, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, United States, 50266
- Mercy Medical Center-West Lakes
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Maryland
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Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
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Michigan
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Ann Arbor, Michigan, United States, 48106
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium NCORP
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Dearborn, Michigan, United States, 48124
- Beaumont Hospital-Dearborn
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Detroit, Michigan, United States, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, United States, 48532
- Genesys Regional Medical Center-West Flint Campus
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
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Grand Blanc, Michigan, United States, 48439
- Genesys Regional Medical Center
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Jackson, Michigan, United States, 49201
- Allegiance Health
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Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49001
- Borgess Medical Center
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Lansing, Michigan, United States, 48912
- Sparrow Hospital
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Livonia, Michigan, United States, 48154
- Saint Mary Mercy Hospital
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Pontiac, Michigan, United States, 48341
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, United States, 48060
- Lake Huron Medical Center
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Saginaw, Michigan, United States, 48601
- Saint Mary's of Michigan
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Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Joplin, Missouri, United States, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, United States, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, United States, 63109
- Saint Louis Cancer and Breast Institute-South City
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP
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Springfield, Missouri, United States, 65807
- CoxHealth South Hospital
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Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
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Nevada
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Las Vegas, Nevada, United States, 89169
- Women's Cancer Center of Nevada
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper Hospital University Medical Center
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New York
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Brooklyn, New York, United States, 11203
- State University of New York Downstate Medical Center
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Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Akron, Ohio, United States, 44304
- Summa Akron City Hospital/Cooper Cancer Center
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, United States, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
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Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
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Mayfield Heights, Ohio, United States, 44124
- Hillcrest Hospital Cancer Center
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Mentor, Ohio, United States, 44060
- Lake University Ireland Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, United States, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Women and Infants Hospital
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent with documented disease progression after appropriate local therapy; acceptable histologic type is defined as carcinosarcoma (malignant mixed muellerian tumor), homologous or heterologous type
- All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria In Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
- Patients must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST version 1.1; 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 at least 90 days following completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient population
- Patients must have a GOG Performance Status of 0, 1, or 2
Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
- Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
- Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
- Patients who have NOT received prior therapy with a taxane (such as paclitaxel or docetaxel) MUST receive a second regimen that includes a taxane
- Patients must have NOT received any additional cytotoxic chemotherapy except as noted above
Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
- Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
- Bilirubin less than or equal to 1.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) less than or equal to 3 x ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
- Neuropathy (sensory and motor) less than or equal to grade 1
- Patients who have met the pre-entry requirements
- Patients of childbearing potential must have a negative serum pregnancy test 72 hours prior to the study entry and be practicing an effective form of contraception
- Patients who have received prior therapy with Ixabepilone
- Patients with a known history of severe (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) grade 3 or 4 hypersensitivity reaction to agents containing Cremophor? EL or its derivatives (eg, polyoxyethylated castor oil)
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients who are pregnant or nursing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Tumor Response
Time Frame: Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days
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Proportion of participants with objective tumor response.
Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
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Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days
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Adverse Events (Grade 3 or Higher) During Treatment Period.
Time Frame: During treatment and up to 30 days after stopping the study treatment
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Number of participants with a maximum grade of 3 or higher during treatment period.
Adverse events are graded and categorized using CTCAE v4.0
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During treatment and up to 30 days after stopping the study treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From study entry to death or last contact, up to 5 years of follow-up.
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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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From study entry to death or last contact, up to 5 years of follow-up.
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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.
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Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first.
Progression is assessed by RECIST 1.1
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From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn McCourt, NRG Oncology
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Neoplasms, Complex and Mixed
- Sarcoma
- Recurrence
- Carcinosarcoma
- Mixed Tumor, Mullerian
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Epothilones
- Epothilone B
Other Study ID Numbers
- NCI-2011-02056 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- U10CA180868 (U.S. NIH Grant/Contract)
- U10CA027469 (U.S. NIH Grant/Contract)
- GOG-0130F (OTHER: CTEP)
- CDR0000681684
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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