Skip to content
Triangle logo TriangleGet started
← Study library

NCT01220609 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-08-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Tumor Response

→

outcome · POSTED

Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0

→

outcome · POSTED

Progression-free Survival

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Ixabepilone
    2. Other: Laboratory Biomarker Analysis
    label
    Treatment (ixabepilone)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (ixabepilone)
    description
    Given IV
    name
    Ixabepilone
    other Names
    1. BMS 247550
    2. BMS-247550
    type
    DRUG
  2. arm Group Labels
    1. Treatment (ixabepilone)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
26
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Tumor Response
    time Frame
    Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.
  2. measure
    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 Outcomes
  1. description
    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.
    measure
    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.
  2. description
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
    measure
    Overall Survival
    time Frame
    From study entry to death or last contact, up to 5 years of follow-up.
Full study description
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.
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.
Source references
references
  1. citation
    Duska LR, Blessing JA, Rotmensch J, Mannel RS, Hanjani P, Rose PG, Dizon DS. A Phase II evaluation of ixabepilone (IND #59699, NSC #710428) in the treatment of recurrent or persistent leiomyosarcoma of the uterus: an NRG Oncology/Gynecologic Oncology Group Study. Gynecol Oncol. 2014 Oct;135(1):44-8. doi: 10.1016/j.ygyno.2014.07.101. Epub 2014 Aug 1.
    pmid
    25091619
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-eb53ae688f20b2623606
      requested nct id
      NCT01220609
      primary nct id
      NCT01220609
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      payload sha256
      d71cc5640511d46248265c4be6146f4f05770fe5eed701dfa670ffca8b58e3ac
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-eb53ae688f20b2623606
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01220609
      occurrences
      1. context exact
        NCT01220609
        end
        11
        exact text
        NCT01220609
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      source json pointer
      /studies/55/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      f2b3e046112ed63f1060422d6995c51fc21a275ed991945ba64ff16f3ace1ddd

    Preserved source evidence · Not medical advice