Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT01220609
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date November 2010
Completion date January 2016

See also
  Status Clinical Trial Phase
Completed NCT01168232 - Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00025220 - Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT00025506 - Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus Phase 2
Terminated NCT01012297 - Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma Phase 3
Completed NCT01548482 - Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Completed NCT00114218 - Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT01154452 - Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma Phase 1/Phase 2
Completed NCT01098630 - Patient, Physician, and Nurse Factors Associated With Entry Onto Clinical Trials and Finishing Treatment in Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
Completed NCT01247571 - Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00031629 - Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT01637961 - Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Phase 2