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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
N/A
Open (Enrolling)
Female
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


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.


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

Type of Study:

Interventional

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:

No

Principal Investigator

Martee Hensley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00169

NCT ID:

NCT00334893

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

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115