Ixabepilone to Treat Cervical Cancer

Stopped early · Phase 2

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

In brief

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.

Key facts

Study ID

NCT00924066

Run by

National Cancer Institute (NCI)

People needed

41

Starts

2008-11-01

Expected to finish

2013-12-01

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with any of the following will be excluded from study entry:
• Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patients physician.
• Patients with a history of CNS (central nervous system) metastases, because symptoms/signs of progressive disease may be confused with drug-related toxicities, unless control has been achieved with either radiation or surgical resection at least three months prior to enrollment on study.
• Patients who are poor medical risk because of other non malignant systemic disease or active, uncontrolled infection.
• Human Immunodeficiency Virus (HIV) positive patients will be considered for eligibility, as long as they are not receiving antiretroviral drugs with strong CYP3A4 (cytochrome P450 3A4) inhibitory activity.
• Prior craniospinal radiation, or total body irradiation (TBI).
• Patients receiving other investigational drugs, or strong CYP3A3 inhibitors (see Section 3.6 for details) that cannot be discontinued or substituted.
• CTCAE (Common Terminology Criteria for Adverse Events) Grade 2 or greater motor or sensory neuropathy.
• Known prior severe hypersensitivity reactions to agents containing Cremophor (Trademark) EL.
• Women with localized disease who are potentially curable through surgical resection.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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