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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01220609
Recruitment Status : Completed
First Posted : October 14, 2010
Results First Posted : November 3, 2015
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Uterine Corpus Sarcoma
Uterine Corpus Leiomyosarcoma
Interventions Drug: Ixabepilone
Other: Laboratory Biomarker Analysis
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ixabepilone
Hide Arm/Group Description Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Period Title: Overall Study
Started 26
Completed 23 [1]
Not Completed 3
Reason Not Completed
Ineligible-Wrong primary cancer site             1
Ineligible- Wrong cell type             1
Ineligible-Never treated             1
[1]
Eligible and treated patients
Arm/Group Title Ixabepilone
Hide Arm/Group Description Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
55.5  (7.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants
40-49 years 5
50-59 years 12
60-69 years 6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
23
 100.0%
Male
0
   0.0%
Histologic Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants
Leiomyosarcoma 22
Carcinosarcoma, malignant mixed Mullerian tumor 1
1.Primary Outcome
Title Tumor Response
Hide 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.
Time Frame Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Ixabepilone
Hide Arm/Group Description:
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 100)
2.Primary Outcome
Title Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Hide Description [Not Specified]
Time Frame Every cycle until completion of study treatment up to 30 days after stopping study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients.
Arm/Group Title Grade 0 Grade 1 (CTCAE v 4.0) Grade 2 (CTCAE v 4.0) Grade 3 (CTCAE v 4.0) Grade 4 (CTCAE v 4.0) Grade 5 (CTCAE v 4.0)
Hide Arm/Group Description:
Number of patients who did not experience the specified AE.
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Overall Number of Participants Analyzed 23 23 23 23 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia
5
  21.7%
5
  21.7%
6
  26.1%
5
  21.7%
2
   8.7%
0
   0.0%
Thrombocytopenia
17
  73.9%
6
  26.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutropenia
8
  34.8%
4
  17.4%
4
  17.4%
3
  13.0%
4
  17.4%
0
   0.0%
Anemia
2
   8.7%
10
  43.5%
6
  26.1%
5
  21.7%
0
   0.0%
0
   0.0%
Platelet count decreased
17
  73.9%
6
  26.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea
16
  69.6%
4
  17.4%
3
  13.0%
0
   0.0%
0
   0.0%
0
   0.0%
Vomiting
19
  82.6%
3
  13.0%
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
Mucositis
20
  87.0%
2
   8.7%
0
   0.0%
1
   4.3%
0
   0.0%
0
   0.0%
Constipation
15
  65.2%
7
  30.4%
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
Diarrhea
18
  78.3%
5
  21.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fatigue
10
  43.5%
10
  43.5%
1
   4.3%
2
   8.7%
0
   0.0%
0
   0.0%
Anorexia
19
  82.6%
2
   8.7%
2
   8.7%
0
   0.0%
0
   0.0%
0
   0.0%
Musculoskeletal/Connective tissue
19
  82.6%
3
  13.0%
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia
20
  87.0%
2
   8.7%
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
Perpheral sensory neuropathy
17
  73.9%
4
  17.4%
2
   8.7%
0
   0.0%
0
   0.0%
0
   0.0%
Dizziness
20
  87.0%
3
  13.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Dyspnea
19
  82.6%
2
   8.7%
1
   4.3%
1
   4.3%
0
   0.0%
0
   0.0%
Alopecia
13
  56.5%
4
  17.4%
6
  26.1%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Progression-free Survival
Hide 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.
Time Frame From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Ixabepilone
Hide Arm/Group Description:
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: months
1.4
(1.2 to 1.6)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame From study entry to death or last contact, up to 5 years of follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Ixabepilone
Hide Arm/Group Description:
Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(4.5 to 13.6)
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ixabepilone
Hide Arm/Group Description Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
All-Cause Mortality
Ixabepilone
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Ixabepilone
Affected / at Risk (%)
Total   9/23 (39.13%) 
Gastrointestinal disorders   
Dysphagia * 1  1/23 (4.35%) 
Colonic Perforation * 1  1/23 (4.35%) 
Abdominal Pain * 1  1/23 (4.35%) 
General disorders   
Pain * 1  1/23 (4.35%) 
Investigations   
Neutrophil Count Decreased * 1  3/23 (13.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms Benign, Malignant And Unspecified * 1  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure * 1  1/23 (4.35%) 
Dyspnea * 1  1/23 (4.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ixabepilone
Affected / at Risk (%)
Total   23/23 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  21/23 (91.30%) 
Cardiac disorders   
Sinus Tachycardia * 1  1/23 (4.35%) 
Chest Pain - Cardiac * 1  1/23 (4.35%) 
Ear and labyrinth disorders   
Tinnitus * 1  2/23 (8.70%) 
External Ear Inflammation * 1  1/23 (4.35%) 
Eye disorders   
Blurred Vision * 1  1/23 (4.35%) 
Gastrointestinal disorders   
Dysphagia * 1  1/23 (4.35%) 
Dyspepsia * 1  1/23 (4.35%) 
Constipation * 1  9/23 (39.13%) 
Diarrhea * 1  5/23 (21.74%) 
Vomiting * 1  4/23 (17.39%) 
Bloating * 1  1/23 (4.35%) 
Abdominal Pain * 1  1/23 (4.35%) 
Mucositis Oral * 1  3/23 (13.04%) 
Ileus * 1  1/23 (4.35%) 
Oral Pain * 1  1/23 (4.35%) 
Abdominal Distension * 1  1/23 (4.35%) 
Nausea * 1  7/23 (30.43%) 
Gastroesophageal Reflux Disease * 1  1/23 (4.35%) 
General disorders   
Pain * 1  1/23 (4.35%) 
Non-Cardiac Chest Pain * 1  1/23 (4.35%) 
Edema Limbs * 1  3/23 (13.04%) 
Fatigue * 1  13/23 (56.52%) 
Fever * 1  1/23 (4.35%) 
Infusion Related Reaction * 1  1/23 (4.35%) 
Immune system disorders   
Allergic Reaction * 1  1/23 (4.35%) 
Infections and infestations   
Urinary Tract Infection * 1  1/23 (4.35%) 
Investigations   
Weight Loss * 1  2/23 (8.70%) 
Weight Gain * 1  1/23 (4.35%) 
Platelet Count Decreased * 1  6/23 (26.09%) 
Neutrophil Count Decreased * 1  15/23 (65.22%) 
Blood Bilirubin Increased * 1  1/23 (4.35%) 
White Blood Cell Decreased * 1  18/23 (78.26%) 
Aspartate Aminotransferase Increased * 1  3/23 (13.04%) 
Alkaline Phosphatase Increased * 1  3/23 (13.04%) 
Alanine Aminotransferase Increased * 1  1/23 (4.35%) 
Metabolism and nutrition disorders   
Hyponatremia * 1  3/23 (13.04%) 
Hypokalemia * 1  2/23 (8.70%) 
Hypocalcemia * 1  2/23 (8.70%) 
Hypoalbuminemia * 1  2/23 (8.70%) 
Hyperglycemia * 1  3/23 (13.04%) 
Dehydration * 1  1/23 (4.35%) 
Anorexia * 1  4/23 (17.39%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  6/23 (26.09%) 
Myalgia * 1  3/23 (13.04%) 
Generalized Muscle Weakness * 1  1/23 (4.35%) 
Bone Pain * 1  1/23 (4.35%) 
Back Pain * 1  2/23 (8.70%) 
Arthralgia * 1  4/23 (17.39%) 
Musculoskeletal And Connective Tissue Disorder - * 1  1/23 (4.35%) 
Nervous system disorders   
Peripheral Sensory Neuropathy * 1  7/23 (30.43%) 
Paresthesia * 1  3/23 (13.04%) 
Movements Involuntary * 1  1/23 (4.35%) 
Headache * 1  1/23 (4.35%) 
Dysgeusia * 1  1/23 (4.35%) 
Dizziness * 1  3/23 (13.04%) 
Psychiatric disorders   
Insomnia * 1  2/23 (8.70%) 
Anxiety * 1  2/23 (8.70%) 
Renal and urinary disorders   
Urinary Frequency * 1  1/23 (4.35%) 
Hematuria * 1  1/23 (4.35%) 
Bladder Spasm * 1  1/23 (4.35%) 
Acute Kidney Injury * 1  1/23 (4.35%) 
Reproductive system and breast disorders   
Vaginal Hemorrhage * 1  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure * 1  1/23 (4.35%) 
Pleural Effusion * 1  1/23 (4.35%) 
Productive Cough * 1  1/23 (4.35%) 
Dyspnea * 1  6/23 (26.09%) 
Cough * 1  1/23 (4.35%) 
Skin and subcutaneous tissue disorders   
Skin Hyperpigmentation * 1  1/23 (4.35%) 
Scalp Pain * 1  1/23 (4.35%) 
Rash Acneiform * 1  2/23 (8.70%) 
Nail Discoloration * 1  1/23 (4.35%) 
Erythema Multiforme * 1  1/23 (4.35%) 
Alopecia * 1  10/23 (43.48%) 
Vascular disorders   
Thromboembolic Event * 1  1/23 (4.35%) 
Lymphedema * 1  2/23 (8.70%) 
Hypotension * 1  1/23 (4.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01220609    
Other Study ID Numbers: NCI-2011-02656
NCI-2011-02656 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000686644
GOG-0131H ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
U10CA180868 ( U.S. NIH Grant/Contract )
First Submitted: October 12, 2010
First Posted: October 14, 2010
Results First Submitted: September 30, 2015
Results First Posted: November 3, 2015
Last Update Posted: August 8, 2019