Phase II Study of Sagopilone Plus Prednisone as First-Time Chemotherapy in Patients with with Metastatic Androgen-Independent Prostate Cancer
Men with a certain type of prostate cancer have been shown to respond to a new chemotherapy drug, Sagopilone, plus prednisone in an international trial led by Oregon Health & Science University Cancer Institute researchers.
The research involved men with androgen-independent prostate cancer that has metastasized, meaning their cancer has spread beyond the prostate and is not longer responding to hormonal therapies. This is the most advanced form of prostate cancer. Prostate cancer is the most common type of cancer in men in the United States, where it is responsible for more male deaths than any other cancer, except lung cancer.
"We are showing solid activity that this drug shows promise," said Tomasz Beer, M.D., principal investigator. He is the Grover C. Bagby Endowed Chair for Cancer Research, director of the Prostate Cancer Research Program at the OHSU Cancer Institute and associate professor of medicine (hematology/medical oncology), OHSU School of Medicine.
This research will be presented Saturday, May 31 at 8 a.m. at the annual American Association of Clinical Oncology in Chicago.
Of the 37 study participants taking the Sagopilone and prednisone long enough to be evaluated, the majority showed positive results in the reduction of their prostate specific antigens, or PSA. PSA is often elevated in the presence of prostate cancer.
During the three-month trial thirteen study participants had a more than 50 percent reduction in their PSA; 23 showed a 30 percent reduction; one who had radiographic measurable disease showed complete response; and four had unconfirmed prostate response. A 30 percent reduction in PSA levels in three months is a strong indicator of survival.
Sagopilone, a fully synthetic derivation, is a new class of drug that inhibits growth and the spread of malignant cell, similar to docetaxel, which has been the gold standard for this type of hormone independent prostate cancer. Docetaxel, however, it is not a cure and not all patients benefit from it. For this reason, Beer and colleagues are committed to searching for new drugs that will be effective against advanced prostate cancer.
"We look forward to completing this study and to the further investigation of Sagopilone as a new treatment option for men with advanced prostate cancer," said Beer.
The study was carried out in collaboration with members of the Prostate Cancer Clinical Trials Consortium, as well as a number of collaborating institutions in the United States and Argentina.
Research sites include: Blair Medical Associates, Altoona, Penn.; Portland Veterans Affairs Medical Center Billings Clinic, Billings, Mont.; Gabrail Cancer Center, Canton, Ohio; University of Nebraska Medical Center; University of Maryland Medical Center, Baltimore, Md.; Pacific Coast Hematology/Oncology Medical group, Fountain Valley, Calif.; Madigan Army Medical Center, Tacoma, Wash.; Veterans Affairs Puget Sound, Seattle, Wash.; John Peter Smith Center for Cancer care, Farmington, N.M.; Eastchester Center for Cancer Care., Bronx, N.Y.; University of Michigan Health System, An Arbor, Mich.; Florida Urology Specialists, Sarasota, Fla.; Hospital Privado Cordoba, Sanatorio Allende, both Cordoba, Argentina; Policlinica Bancaria, Hospital Alvarez, Hospital Durand and Hospital Britanico, all in Buenos Aires, Argentina.
Sagopilone is an experimental drug made by Bayer Healthcare Pharmaceuticals, which has funded this research.
About the OHSU Cancer Institute
The OHSU Cancer Institute is the only National Cancer Institute-designated center between Sacramento and Seattle. It comprises some 200 clinical researchers, basic scientists and population scientists who work together to translate scientific discoveries into longer and better lives for Oregon's cancer patients. In the lab, basic scientists examine cancer cells and normal cells to uncover molecular abnormalities that cause the disease. This basic science informs more than 300 clinical trials conducted at the OHSU Cancer Institute.
Oregon Health & Science University is the state's only health and research university, and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government), with 12,400 employees. OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.