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Clinical Trial Summary

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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00924066
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase Phase 2
Start date November 2008
Completion date December 2013

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