A Phase II Evaluation Of Epothilone-B BMS 247550 (IND # 59,669 NSC # 710428) In The Treatment Of Recurrent Or Persistent Platinum And Paclitaxel Refractory Ovarian Or Primary Peritoneal Cancer
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent
platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.
II. Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE:
Patients receive ixabepilone IV over 1 hour. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity. Patients with a complete response (CR)
receive 2 additional courses after achieving CR.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response
Up to 5 years
No
David R. Spriggs
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2012-02413
NCT00025155
July 2002
Name | Location |
---|---|
Gynecologic Oncology Group | Philadelphia, Pennsylvania 19103 |