Cervical Carcinoma Clinical Trial
Official title:
A Phase II Clinical Trial of Ixabepilone (Ixempra [R], BMS-247550, NSC 710428), an Epothilone B Analog, in Cervical Cancer
Background:
- Ixabepilone is a member of the class of drugs called epothilones. These drugs interfere
with the ability of cancer cells to replicate.
- Epothilones are similar to taxanes, another class of drugs, which includes the drug
Taxol. Taxol is widely used to treat a variety of cancers.
- Ixabepilone can work in cells that are resistant to Taxol.
Objectives:
- To determine whether ixabepilone is effective for treating cervical cancer.
Eligibility:
- Women 18 years of age or older with cervical cancer.
Design:
- Patients receive ixabepilone intravenously (through a vein) over 60 minutes on the first
5 days of each 21-day treatment cycle. Their dosage may be adjusted according to how
their bodies respond to the drug.
- The number of cycles each woman receives depends on her response to the treatment.
- Patients have CT (computed tomography) scans and other tests before starting treatment
and then every other treatment cycle to determine the response of the tumor to
ixabepilone.
- Patients who can undergo a tumor biopsy (surgical removal of a sample of tumor tissue)
are asked to have a biopsy done before starting treatment with ixabepilone and again on
the fourth or fifth day of treatment. This procedure is optional.
Background
- 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.
Objectives
Primary-
- 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 (partial response) +CR (complete response)).
Secondary-
- 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
target.
- Estimate progression-free survival and duration of response.
Eligibility
- 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.
Design
- Phase II study, open, non-randomized
- Ixabepilone will be administered at a dose of 6mg/m^2 daily on days 1 through 5, every
three weeks.
- Restaging will be done every two cycles using RECIST (Response Evaluation Criteria in
Solid Tumors)
- Planned maximum enrollment 76 persons
;
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