Full Text View
Tabular View
No Study Results Posted
Related Studies
E7389 in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
This study is currently recruiting participants.
Study NCT00334893   Information provided by National Cancer Institute (NCI)
First Received: June 7, 2006   Last Updated: April 30, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 7, 2006
April 30, 2009
April 2006
Objective response rate [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00334893 on ClinicalTrials.gov Archive Site
Toxicity profile of E7389 [ Designated as safety issue: Yes ]
Same as current
 
E7389 in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well E7389 works in treating patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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 E7389 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.

PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
Drug: eribulin mesylate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
74
 
January 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from effects of recent surgery, radiotherapy, or chemotherapy
  • No more than 2 prior cytotoxic therapies with no more than 1 nonplatinum, nontaxane 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
Female
18 Years and older
No
 
United States
 
 
NCT00334893
David Paul Kelsen, Memorial Sloan-Kettering Cancer Center
MSKCC-06027, NCI-7431
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Martee L. Hensley, MD Memorial Sloan-Kettering Cancer Center
Investigator: Carol Aghajanian, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.