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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Fallopian Tube Cancer

Treatments: Drug: eribulin mesylate

Study type: Interventional

Funder types: NIH

Identifiers

NCT00334893

N01CM62206 (U.S. NIH Grant/Contract)

P30CA008748 (U.S. NIH Grant/Contract)

NCI-7431

06-027 (Other Identifier)

MSKCC-06027

NCI-2009-00169 (Registry Identifier)

CDR0000481534

7431 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Treatment (chemotherapy)

Experimental group

Description:

Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment:

Drug: eribulin mesylate