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Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT00334893
Recruitment Status : Completed
First Posted : June 8, 2006
Results First Posted : December 10, 2013
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well eribulin mesylate works in treating patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Drug: eribulin mesylate Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the frequency of objective response (complete and partial responses) in patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with E7389 (eribulin mesylate).

SECONDARY OBJECTIVES:

II. Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no).

Patients receive eribulin mesylate intravenously (IV) over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Study Start Date : April 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012


Arm Intervention/treatment
Experimental: Treatment (chemotherapy)
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog




Primary Outcome Measures :
  1. Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer. [ Time Frame: up to a total of a year ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Secondary Outcome Measures :
  1. Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer [ Time Frame: From the time of their first treatment with eribulin mesylate ]
    Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer

    • Recurrent disease after ≥ 1 prior therapy, meeting 1 of the following criteria:

      • Platinum-resistant disease (progression-free interval < 6 months)
      • Platinum-sensitive disease (progression-free interval ≥ 6 months)
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known brain metastasis
  • Life expectancy > 2 months
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • WBC ≥ 3,000/mm^3
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatine normal OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

    • Stage IA or IB endometrial cancer within the past 5 years allowed provided patient is considered disease free
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to E7389
  • No HIV positivity
  • No ongoing or active infection
  • No cardiac arrhythmia
  • No unstable angina pectoris
  • No symptomatic congestive heart failure
  • No psychiatric illness or social situations that would preclude study compliance
  • No other uncontrolled intercurrent illness
  • See Disease Characteristics
  • Recovered from effects of recent surgery, radiotherapy, or chemotherapy
  • No more than 2 prior cytotoxic therapies with no more than 1 non platinum, non taxane regimen
  • No prior E7389
  • More than 14 days since prior hormonal therapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • More than 4 weeks since prior radiotherapy
  • No concurrent antitumor hormonal therapy
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No granulocyte colony-stimulating factors during the first course of 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): NCT00334893


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Martee Hensley Memorial Sloan Kettering Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00334893     History of Changes
Obsolete Identifiers: NCT01645592, NCT01664403
Other Study ID Numbers: NCI-2009-00169
NCI-2009-00169 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-06027
NCI-7431
CDR0000481534
06-027 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
7431 ( Other Identifier: CTEP )
P30CA008748 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2006    Key Record Dates
Results First Posted: December 10, 2013
Last Update Posted: November 29, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases