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New Chemotherapy Drug for Advanced Cervical Cancer

Name of the Trial
Phase II Clinical Trial of Ixabepilone (Ixempra, BMS-247550, NSC 710428), an Epothilone B Analog, in Cervical Cancer (NCI-09-C-0037). See the protocol summary.

Principal Investigator
Dr. Antonio Tito Fojo, NCI Center for Cancer Research

Dr. Antonio Tito Fojo
Dr. Antonio Tito Fojo
Principal Investigator

Why This Trial Is Important
Women with advanced cervical cancer that cannot be treated surgically may benefit from chemotherapy given with or without radiation therapy. Several chemotherapy drugs, including taxanes and platinum-based drugs, have shown some activity in patients with advanced disease. Unfortunately, response rates to these drugs tend to be low and the response durations brief. Doctors are eager to develop better chemotherapy treatments for these patients.

In preliminary studies, a new drug called ixabepilone (Ixempra) has shown promise in treating women with advanced cervical cancer. Ixabepilone belongs to a class of drugs called epothilones. Like taxanes, epothilones stabilize cellular structures called microtubules, which are involved in many important processes, including cell division. Depending on the needs of the cell, microtubules either increase or decrease in size, and, when they are prevented from changing (e.g., by microtubule-stabilizing drugs), they cannot function normally. As a result, cell division is inhibited. The epothilones are thought to be more potent than the taxanes, and mechanisms that make cancer cells resistant to taxanes and other drugs do not appear to confer resistance to epothilones.

In this clinical trial, women with cervical cancer that has recurred or demonstrated resistance to previous chemotherapy and that cannot be treated surgically will receive ixabepilone as a 1-hour intravenous infusion on the first 5 days of a 3-week cycle. The number of cycles a woman receives will depend on how her cancer responds to the drug. Doctors will assess whether tumors shrink or disappear (response rate), as well as the drug’s effects on cell division and cell death.

“Drugs that target the microtubules are among the most widely used in oncology,” said Dr. Fojo. “They are effective in a broad range of cancers, and our goal with this study, as well as a similar study in kidney cancer, is to see if a type of drug we believe is an improvement on the taxanes will actually improve outcomes for patients with these diseases.

“Ixabepilone is already approved by the FDA for second-line treatment of advanced breast cancer, and the regimen that we are using has been demonstrated to be very tolerable in an earlier study,” he added.

For More Information
See the lists of eligibility criteria and trial contact information or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll free and confidential.

  • Posted: April 6, 2010