Brief Title
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Secondary Outcome
Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
Condition
Fallopian Tube Cancer
Intervention
eribulin mesylate
Study Arms / Comparison Groups
Treatment (chemotherapy)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
74
Start Date
April 2006
Completion Date
March 2012
Primary Completion Date
March 2012
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Martee Hensley, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00334893
Organization ID
NCI-2009-00169
Secondary IDs
NCI-2009-00169
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Martee Hensley, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
October 2017