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A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Phase 2
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

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Trial Information

A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer


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).


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (CR + PR) to treatment with eribulin mesylate in patients with recurrent ovarian, fallopian tube, or peritoneal cancer

Outcome Description:

Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Reported separately for patients with platinum-resistant disease and potentially platinum-sensitive disease. The 95% confidence intervals should be provided.

Outcome Time Frame:

Baseline and every 6 weeks

Safety Issue:


Principal Investigator

Martee Hensley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Dana-Farber Cancer Institute Boston, Massachusetts  02115