BETHESDA, Md--Hoping to resolve one of cancer care's ongoing controversies, the National Cancer Institute is launching the first large national study of high-dose chemotherapy for advanced ovarian cancer, to be conducted at dozens of medical centers affiliated with the Gynecologic Oncology Group and other cooperative groups supported by NCI.
The randomized study will enroll 275 women with stage III ovarian cancer who still show evidence of disease after surgery and one course of chemotherapy.
One group will receive a three-drug combination--carboplatin (Paraplatin), mitoxantrone(Drug information on mitoxantrone) (Novantrone), and cyclophosphamide(Drug information on cyclophosphamide)--and autologous bone marrow transplantation.
The second group will receive paclitaxel(Drug information on paclitaxel) (Taxol) and carboplatin(Drug information on carboplatin), the drug combination now considered the optimal therapy for stage III ovarian cancer. Endpoints will be overall survival and progression-free survival. Researchers will also seek to measure differences in quality of life, including both physical and psychological well-being.
"This trial should help resolve the debate over whether high-dose chemotherapy is more, equally, or less effective, compared to conventional chemotherapy," said Edward L. Tremble, MD, of NCI's Clinical Investigations Branch, Division of Cancer Treatment, Diagnosis, and Centers.