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Tracking Information | |||||||||
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First Received Date † | June 7, 2006 | ||||||||
Last Updated Date | April 30, 2009 | ||||||||
Start Date † | April 2006 | ||||||||
Current Primary Outcome Measures † |
Objective response rate [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00334893 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
Toxicity profile of E7389 [ Designated as safety issue: Yes ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | E7389 in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer | ||||||||
Official Title † | A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer | ||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well E7389 works in treating patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no). Patients receive E7389 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. PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study. |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Open Label | ||||||||
Condition † |
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Intervention † | Drug: eribulin mesylate | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 74 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00334893 | ||||||||
Responsible Party | David Paul Kelsen, Memorial Sloan-Kettering Cancer Center | ||||||||
Secondary IDs †† | MSKCC-06027, NCI-7431 | ||||||||
Study Sponsor † | Memorial Sloan-Kettering Cancer Center | ||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | December 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |