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

Completed · Phase 2

Conditions studied: Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma

In brief

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.

Key facts

Study ID

NCT01220609

Run by

National Cancer Institute (NCI)

People needed

26

Starts

2010-11-01

Expected to finish

2016-01-01

Last updated by the study team

2019-08-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Florida Gynecologic Oncology — Fort Myers, Florida, United States
• John B Amos Cancer Center — Columbus, Georgia, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Sudarshan K Sharma MD Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Cadence Cancer Center in Warrenville — Warrenville, Illinois, United States
• Saint Vincent Oncology Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Michigan Cancer Research Consortium Community Clinical Oncology Program — Ann Arbor, Michigan, United States
• Oakwood Hospital and Medical Center — Dearborn, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Saint John Hospital and Medical Center — Detroit, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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