A Phase II Clinical Trial of Ixabepilone (Ixempra [R], BMS-247550, NSC 710428), an Epothilone B Analog, in Cervical Cancer
- Ixabepilone (Ixempra (Trademark), BMS-247550, NSC 710428) is a semi-synthetic analog of
the natural product epothilone B.
- The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained
from the fermentation of the cellulose degrading myxobacteria, Sorangium cellulosum.
- Ixabepilone is active against cancer models that are naturally insensitive to
paclitaxel or have developed resistance to paclitaxel, both in-vitro and in-vivo.
- Establish the efficacy of the investigational agent ixabepilone in patients with cervical
carcinoma when administered as a daily one-hour infusion on days 1 to 5 every three weeks,
as measured by overall response (PR+CR).
- Assess pharmacodynamic endpoints to determine the extent of tubulin polymerization and
whether or not there has been activation of cellular death pathways distal to the
- Estimate progression-free survival and duration of response.
- Age greater than 18
- Histologic or cytologic confirmation of cervical carcinoma; either squamous cell or
non-squamous consisting of cervical adenocarcinoma, cervical adenosquamous carcinoma or
cervical carcinoma, non-squamous type.
- Phase II study, open, non-randomized
- Ixabepilone will be administered at a dose of 6mg/m(2) daily on days 1 through 5, every
- Restaging will be done every two cycles using RECIST
- Planned maximum enrollment 76 persons
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Establish the efficacy of the investigational agent ixabepilone in patients with cervical carcinoma when administered as a daily one-hour infusion on days 1 to 5 every three weeks.
Antonio T Fojo, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|