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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334893 |
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.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: eribulin mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer |
Estimated Enrollment: | 74 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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:
PATIENT CHARACTERISTICS:
No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Suzanne T. Berlin, DO 617-632-2334 | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Martee L. Hensley, MD 212-639-6902 |
Study Chair: | Martee L. Hensley, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Carol Aghajanian, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000481534, MSKCC-06027, NCI-7431 |
Study First Received: | June 7, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00334893 |
Health Authority: | Unspecified |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Fallopian Tube Neoplasms |
Recurrence Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |