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

NCT01220609 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2011-02656CDR0000686644GOG-0131HU10CA027469U10CA180868
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 72

Brief 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.

Conditions

Recurrent Uterine Corpus Sarcoma; Uterine Corpus Leiomyosarcoma

Outcome Measures

Primary Outcomes (2)

• Tumor Response

  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.

  Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.

• Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0

  Every cycle until completion of study treatment up to 30 days after stopping study treatment

Secondary Outcomes (2)

• Progression-free Survival

  From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.

• Overall Survival

  From study entry to death or last contact, up to 5 years of follow-up.

Study Arms (1)

Treatment (ixabepilone)

EXPERIMENTAL

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Ixabepilone; Other: Laboratory Biomarker Analysis

Interventions

Ixabepilone DRUG

Given IV

Also known as: BMS 247550, BMS-247550

Treatment (ixabepilone)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ixabepilone)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• NRG Oncology: collaborator

Study Sites (72)

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, 85012, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Florida Gynecologic Oncology

Fort Myers, Florida, 33905, United States

Location

John B Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Hinsdale, Illinois, 60521, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699, United States

Location

Cadence Cancer Center in Warrenville

Warrenville, Illinois, 60555, United States

Location

Saint Vincent Oncology Center

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

Michigan Cancer Research Consortium Community Clinical Oncology Program

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Hospital and Medical Center

Dearborn, Michigan, 48124, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Saint Joseph Mercy Port Huron

Port Huron, Michigan, 48060, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Phelps County Regional Medical Center

Rolla, Missouri, 65401, United States

Location

Saint John's Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, 44304, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, 18201, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29615, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

Location

Oconomowoc Memorial Hospital-ProHealth Care Inc

Oconomowoc, Wisconsin, 53066-3896, United States

Location

Waukesha Memorial Hospital - ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (1)

• Duska LR, Blessing JA, Rotmensch J, Mannel RS, Hanjani P, Rose PG, Dizon DS. A Phase II evaluation of ixabepilone (IND #59699, NSC #710428) in the treatment of recurrent or persistent leiomyosarcoma of the uterus: an NRG Oncology/Gynecologic Oncology Group Study. Gynecol Oncol. 2014 Oct;135(1):44-8. doi: 10.1016/j.ygyno.2014.07.101. Epub 2014 Aug 1.

  PMID: 25091619 DERIVED

MeSH Terms

Interventions

ixabepilone

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center - Buffalo

kurasa@nrgoncology.org

716-845-7733

Study Officials

• Linda Duska

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: January 1, 2016
• Last Updated: August 8, 2019
• Results First Posted: November 3, 2015

Record last verified: 2019-08

Locations

US (72)