Trials / Terminated

TerminatedNCT00924066

Ixabepilone to Treat Cervical Cancer

A Phase II Clinical Trial of Ixabepilone (Ixempra [R], BMS-247550, NSC 710428), an Epothilone B Analog, in Cervical Cancer

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 41 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: Female
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

Interventions

Type	Name	Description
DRUG	Ixempra (Ixabepilone (BMS-247550) )	Participants received Ixabepilone 6mg/m\^2 for a total of 30mg/m\^2 inpatient or outpatient intravenously over an hour on the first five days of each 21 day cycle.

Timeline

Start date: 2008-11-01
Primary completion: 2013-12-01
Completion: 2013-12-01
First posted: 2009-06-18
Last updated: 2019-11-21
Results posted: 2014-06-09

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT00924066. Inclusion in this directory is not an endorsement.