This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01168232
First received: July 22, 2010
Last updated: November 28, 2016
Last verified: November 2016
  Purpose
This phase II trial is studying the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.

Condition Intervention Phase
Recurrent Uterine Sarcoma Uterine Carcinosarcoma Drug: ixabepilone Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective Tumor Response [ Time Frame: Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days ]
    Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.

  • Adverse Events (Grade 3 or Higher) During Treatment Period. [ Time Frame: During treatment and up to 30 days after stopping the study treatment ]
    Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0


Secondary Outcome Measures:
  • 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 is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1

  • 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.


Enrollment: 42
Study Start Date: September 2010
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the response rate of patients with persistent or recurrent carcinosarcoma of the uterus treated with ixabepilone.

II. To determine the nature and degree of toxicity of this regimen in these patients.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival of patients treated with this regimen.

TERTIARY OBJECTIVES:

I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.

II. To explore the association between class III beta-tubulin expression with response, progression-free survival, and overall survival in these patients.

OUTLINE: This is a multicenter study.

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

Tumor tissue samples from prior surgery may be collected for class III beta-tubulin analysis by IHC.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed uterine carcinosarcoma

    • Persistent or recurrent disease refractory to curative or established treatments
    • Malignant mixed müllerian tumor
    • Homologous or heterologous type
  • Progressive disease after local therapy
  • 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
  • Patient 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 after completion of radiotherapy
  • Patient must have had 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have included chemotherapy, chemotherapy and radiotherapy, and/or consolidation/maintenance therapy

    • Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is counted as a systemic chemotherapy regimen
    • Patients who have not received a prior taxane therapy (e.g., paclitaxel or docetaxel) must receive a second regimen that includes a taxane
  • Patients must not be eligible for a higher priority GOG or Rare Tumor protocol, if one exists
  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 3.0 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Peripheral neuropathy (sensory and motor) ≤ grade 1
  • No active infection requiring antibiotics except uncomplicated urinary tract infection
  • No history of severe grade 3-4 hypersensitivity reaction to agents containing Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)
  • More than 3 years since other invasive malignancy except non-melanoma skin cancer
  • No concurrent amifostine or other protective reagents
  • Recovered from recent surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior hormonal therapy
  • At least 3 weeks since any prior therapy directed at the malignant tumor, including biological and immunological agents
  • One prior non-cytotoxic (biologic or cytostatic) regimen for management of recurrent or persistent disease that includes, but is not limited to, any of the following allowed:

    • Monoclonal antibodies
    • Cytokines
    • Small-molecule inhibitors of signal transduction
  • More than 3 years since prior radiotherapy to any portion of the abdominal cavity or pelvis other than for uterine carcinosarcoma

    • Prior radiation for localized cancer of the breast, head and neck, or skin allowed provided the patient remains free of recurrent or metastatic disease
  • No prior chemotherapy for any abdominal or pelvic tumor, other than for uterine carcinosarcoma, within the past 3 years

    • More than 3 years since prior adjuvant chemotherapy for localized breast cancer allowed provided patient has remained free of recurrent or metastatic disease
  • No prior ixabepilone
  • No prior cancer therapy that contraindicates study treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168232

  Show 76 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carolyn McCourt Gynecologic Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01168232     History of Changes
Other Study ID Numbers: NCI-2011-02056
NCI-2011-02056 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0130F
CDR0000681684
GOG-0130F ( Other Identifier: Gynecologic Oncology Group )
GOG-0130F ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
Study First Received: July 22, 2010
Results First Received: September 19, 2016
Last Updated: November 28, 2016

Additional relevant MeSH terms:
Uterine Neoplasms
Carcinosarcoma
Mixed Tumor, Mullerian
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Epothilones
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 29, 2017