In an effort to resolve one of the ongoing controversies in cancer care, the National Cancer Institute (NCI) has launched the first large national study of high-dose chemotherapy for ovarian cancer with transplantation of bone marrow blood stem cells. The new study is expected to answer critical questions about the use of this intensive therapy in women with advanced ovarian cancer.
"This trial should help resolve the debate over whether high-dose chemotherapy is more, equally or less effective compared to conventional chemotherapy," said Edward Trimble, MD, of the NCI at a meeting of the Gynecologic Oncology Group held January 17-19 in Denver. "We also expect the trial to tell us more about the impact of this treatment on quality of life."
"I am hopeful that this study will lead us to understand more about the effectiveness of high-dose chemotherapy for advanced ovarian cancer," said Connecticut congresswoman Rosa DeLauro. "As a survivor of this particular form of cancer, I am especially grateful for the work NCI is doing to increase the survival rate for this deadly disease."
The new study will enroll 275 women with advanced (stage III) ovarian cancer who still have evidence of disease after undergoing surgery and one course of chemotherapy. The women will be divided randomly into two groups. One group will receive high doses of three drugs--carboplatin (Paraplatin), mitoxantrone(Drug information on mitoxantrone) (Novantrone), and cyclophosphamide(Drug information on cyclophosphamide) (Cytoxan, Neosar)--with autologous stem-cell transplantation. The second group will receive paclitaxel(Drug information on paclitaxel) (Taxol) and carboplatin(Drug information on carboplatin), a combination now widely considered to be an optimal therapy for this stage of ovarian cancer.
The researchers will compare the two treatments by measuring their effects on overall and progression-free survival. They will also attempt to assess any 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 several other cooperative trial groups that NCI supports.
Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. In 1996, approximately 26,700 new cases were diagnosed and about 14,800 women died of the disease. Despite its initial responsiveness to chemotherapy, ovarian cancer has remained difficult to cure. The vast majority of cases are not diagnosed until they have reached one of the later stages. Among women with stage III disease, 49% survive for 5 years after diagnosis.