Ixabepilone to Treat Cervical Cancer

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

Status Terminated

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 ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Carcinoma
• Cervical Carcinoma, Non-SquamousType
• Uterine Cervical Neoplasms

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