Status:
COMPLETED
Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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 cance...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00334893
Start Date
April 1 2006
End Date
March 1 2012
Last Update
November 29 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065