Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy
|ClinicalTrials.gov Identifier: NCT01220609|
Recruitment Status : Completed
First Posted : October 14, 2010
Results First Posted : November 3, 2015
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma||Drug: Ixabepilone Other: Laboratory Biomarker Analysis||Phase 2|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus|
|Study Start Date :||November 2010|
|Primary Completion Date :||July 2014|
|Study Completion Date :||January 2016|
Experimental: Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
- Tumor Response [ Time Frame: Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years. ]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.
- 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 ]
- 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. ]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.
- Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years of follow-up. ]Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220609
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|Principal Investigator:||Linda Duska||NRG Oncology|