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Reprinted from the NCI Cancer Bulletin, vol. 3/no. 37, Sept. 26, 2006 (see the current issue ³).

A phase III randomized trial has shown a statistically significant improvement in progression-free survival for women with platinum-sensitive recurrent ovarian cancer given gemcitabine with carboplatin compared with carboplatin alone, without any significant differences in quality of life. The results, published early online September 18, 2006, by the Journal of Clinical Oncology, come from an international collaborative trial comprising investigators from Europe, Canada, and the United States (see the journal abstract).

Investigators randomly assigned 356 women with recurrent ovarian cancer whose tumors had previously responded to first-line therapy with a platinum-based regimen to receive either carboplatin alone or carboplatin plus gemcitabine, and compared progression-free survival, side effects, and overall quality of life.

Though more high-grade hematologic (blood-related) side effects and a greater incidence of alopecia (hair loss) were seen in patients taking carboplatin and gemcitabine, few patients in either arm discontinued treatment. The median progression-free survival was 8.6 months for patients taking carboplatin and gemcitabine, and 5.8 months for patients taking carboplatin alone. The benefit provided by the addition of gemcitabine persisted even after adjusting the data for other factors that could affect progression-free survival. Quality-of-life questionnaires showed no statistically significant differences between the two groups of patients.

"Gemcitabine plus carboplatin represents a new treatment option for patients with platinum-sensitive recurrent ovarian cancer," stated the authors. Such new therapeutic regimens are badly needed, they explained, because cumulative neurotoxicity limits the reuse of taxane, and platinum combinations often are used as first-line therapy in the disease.

Glossary Terms

Initial treatment used to reduce a cancer. First-line therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains. Also called induction therapy, primary therapy, and primary treatment.

A statistics term. The middle value in a set of measurements.

The tendency of some treatments to cause damage to the nervous system.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

A metal that is an important component of some anticancer drugs, such as cisplatin and carboplatin.

The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works. Also called PFS.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.

A type of drug that blocks cell growth by stopping mitosis (cell division). Taxanes interfere with microtubules (cellular structures that help move chromosomes during mitosis). They are used to treat cancer. A taxane is a type of mitotic inhibitor and antimicrotubule agent.