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

Completed · Phase 2

Conditions studied: Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

In brief

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.

Key facts

Study ID

NCT00334893

Run by

National Cancer Institute (NCI)

People needed

74

Starts

2006-04-01

Expected to finish

2012-03-01

Last updated by the study team

2017-11-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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