NCT01168232 · REGISTRY CONDITION SEARCH

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

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 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.

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

Objective Tumor Response

→

outcome · POSTED

Adverse Events (Grade 3 or Higher) During Treatment Period.

→

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: * 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
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: Ixabepilone
Other: Laboratory Biomarker Analysis
label
Treatment (ixabepilone)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (ixabepilone)
description
Given IV
name
Ixabepilone
other Names
(1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione
Azaepothilone B
BMS 247550
BMS-247550
BMS247550
Epothilone
Epothilone-B BMS 247550
Ixempra
type
DRUG
arm Group Labels
Treatment (ixabepilone)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 42
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
measure
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
description
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0
measure
Adverse Events (Grade 3 or Higher) During Treatment Period.
time Frame
During treatment and up to 30 days after stopping the study treatment

secondary Outcomes

description
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
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.
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 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.
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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-e74d2db7f86a54d4ec46
requested nct id
NCT01168232
primary nct id
NCT01168232
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
payload sha256
f3cde0f2dd59ded078fda37cb004c91198eec892ebae38e4dfa70739e3d95cf7
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-e74d2db7f86a54d4ec46
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01168232
occurrences
context exact
NCT01168232
end
11
exact text
NCT01168232
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/14/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
0319f8cdcc803342474316b10a29fe7f2201c775604caefea5c590ce36894d44
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice