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Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

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: NCT00095979
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : May 21, 2015
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.

Condition or disease Intervention/treatment Phase
Endometrial Adenocarcinoma Recurrent Endometrial Carcinoma Stage IV Endometrial Carcinoma Drug: ixabepilone Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date : May 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ixabepilone

Arm Intervention/treatment
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.
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra




Primary Outcome Measures :
  1. Tumor Response [ Time Frame: Every other cycle for first 6 months; then every six 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 ]
    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. 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.

  2. Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) [ Time Frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months) ]

Secondary Outcome Measures :
  1. 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 is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed endometrial adenocarcinoma

    • Recurrent or persistent disease

      • Histologic confirmation of the original primary tumor is required
    • Not amenable to management with any of the following:

      • Surgery
      • Radiotherapy
      • Higher priority or standard chemotherapy
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
  • At least 1 target lesion

    • Tumors within a previously irradiated field are designated as non-target lesions
    • Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy
  • Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma
  • Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population)
  • Performance status - GOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST (aspartate aminotransferase) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Sensory or motor neuropathy ≤ grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other invasive malignancies within the past 5 years except non-melanoma skin cancer
  • At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor
  • One prior non-cytotoxic* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed
  • See Disease Characteristics
  • Prior paclitaxel or docetaxel allowed
  • Recovered from prior chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)
  • No prior ixabepilone
  • At least 1 week since prior hormonal therapy directed at the malignant tumor

    • Continuation of hormone replacement therapy allowed
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • Recovered from prior surgery
  • At least 3 weeks since other prior therapy directed at the malignant tumor
  • No prior cancer treatment that contraindicates study therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095979


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Gynecologic Oncology Group
Investigators
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Principal Investigator: Don Dizon Gynecologic Oncology Group
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095979    
Other Study ID Numbers: NCI-2012-02628
NCI-2012-02628 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000391849
GOG-0129P ( Other Identifier: Gynecologic Oncology Group )
GOG-0129P ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2004    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: July 24, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Epothilones
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents