NCI Launches Study of High-Dose Chemotherapy With Stem-Cell Transplants for Ovarian Cancer

In an effort to resolve one of the ongoing controversies in cancer care,the National Cancer Institute (NCI) has launched the first large nationalstudy of high-dose chemotherapy for ovarian cancer with transplantationof bone marrow blood stem cells. The new study is expected to answer criticalquestions about the use of this intensive therapy in women with advancedovarian cancer.

"This trial should help resolve the debate over whether high-dosechemotherapy is more, equally or less effective compared to conventionalchemotherapy," said Edward Trimble, MD, of the NCI at a meeting ofthe Gynecologic Oncology Group held January 17-19 in Denver. "We alsoexpect the trial to tell us more about the impact of this treatment onquality of life."

"I am hopeful that this study will lead us to understand more aboutthe effectiveness of high-dose chemotherapy for advanced ovarian cancer,"said Connecticut congresswoman Rosa DeLauro. "As a survivor of thisparticular form of cancer, I am especially grateful for the work NCI isdoing to increase the survival rate for this deadly disease."

The new study will enroll 275 women with advanced (stage III) ovariancancer who still have evidence of disease after undergoing surgery andone course of chemotherapy. The women will be divided randomly into twogroups. One group will receive high doses of three drugs--carboplatin (Paraplatin),mitoxantrone (Novantrone), and cyclophosphamide (Cytoxan, Neosar)--withautologous stem-cell transplantation. The second group will receive paclitaxel(Taxol) and carboplatin, a combination now widely considered to be an optimaltherapy for this stage of ovarian cancer.

The researchers will compare the two treatments by measuring their effectson overall and progression-free survival. They will also attempt to assessany differences in quality of life between women on the two treatments,including both physical and psychological well-being.

The study will take place at dozens of research centers around the country,all members of either the Gynecologic Oncology Group or one of severalother cooperative trial groups that NCI supports.

Ovarian cancer is the leading cause of death from gynecologic cancerin the United States. In 1996, approximately 26,700 new cases were diagnosedand about 14,800 women died of the disease. Despite its initial responsivenessto chemotherapy, ovarian cancer has remained difficult to cure. The vastmajority of cases are not diagnosed until they have reached one of thelater stages. Among women with stage III disease, 49% survive for 5 yearsafter diagnosis.