Ixabepilone to Treat Cervical Cancer

Phase 2

Terminated

Conditions: Cervical Carcinoma
Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Carcinoma, Non-SquamousType

Interventions: Drug: Ixempra (Ixabepilone (BMS-247550) )

Registration Number: NCT00924066

Lead Sponsor: National Cancer Institute (NCI)

Brief 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

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Squamous and Nonsquamous participants	Ixempra (Ixabepilone (BMS-247550) )	Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix. Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Tumor Response (PR + CR) Per RECIST	Every 6 weeks, up to 15 months	Establish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Serious and Non-Serious Adverse Events	Date treatment consent signed to date off study, approximately 61 months	Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.