Clinical trial NCT00334893: Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Official title: A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-06-08
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
timeFrame: up to a total of a year
Secondary outcomes:
measure: Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
timeFrame: From the time of their first treatment with eribulin mesylate
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Martee Hensley
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20.