HOUSTON, Jan. 30 /PRNewswire/ -- Leading cancer researchers affiliated with the US Oncology Research Network presented findings from a Phase II clinical study testing single agent pemetrexed in patients with advanced and metastatic hepatoma (primary liver cancer), and a phase II clinical study testing gemcitabine plus zoledronic acid on subjects with Stage IV pancreatic cancer.
The findings were presented at the 2006 Gastrointestinal Cancers Symposium Jan. 26-28 in San Francisco by physicians affiliated with US Oncology, Inc., one of the nation’s largest health care services networks focused exclusively on cancer treatment and research.
“We are pleased to announce the findings of this research at this important conference,” said Dr. Thomas Cartwright of Ocala Oncology, an affiliate of US Oncology, Inc. “Every opportunity we have to present our research and discuss our efforts with other experts in the field is an opportunity to advance the science of cancer research.”
The presentations included:
Single-agent pemetrexed in patients with advanced and metastatic hepatoma Researchers: Allen L. Cohn, M.D., Rocky Mountain Cancer Center, Midtown; J. William Myers, M.D., Texas Oncology, P.A., South Austin; Steven Mamus, M.D., Cancer Centers of Florida, Gore; Charles Deur, M.D., Texas Oncology, P.A., Arlington North; Steven Nichol, M.D., Eli Lilly; Karen Hood, M.S.N., Eli Lilly; Muhammad M. Khan, M.B.B.S., US Oncology Research; Des Ilegbodu, Dr.PH., US Oncology Research; Jean Kochis, M.B.A., US Oncology Research; Lina Asmar, Ph.D., US Oncology Research.
The incidence of hepatoma is rising in the United States, primarily due to the increase in the prevalence of hepatitis C. Surgical treatments are rarely an option for patients with advanced hepatoma, and while chemotherapy, particularly with doxorubicin-based regimens, has marginally prolonged survival, response rates have been poor with the burden of high toxicity. Pemetrexed (ALIMTA(R)), a folate antimetabolite, has demonstrated activity in hepatoma cell lines with a manageable toxicity profile, making it a potentially useful agent in hepatocellular carcinoma.
A multicenter, phase II study was conducted to assess the response rate and evaluate the toxicity profile of single-agent pemetrexed in first-line patients with advanced or metastatic hepatoma.
Pemetrexed 600 mg/m2 IV was administered on day one of each 21-day cycle until disease progression (PD). Patients were premedicated with dexamethasone 4 mg PO BID and received daily folic acid 350-1000 ug PO and Vitamin B12 1000 ug IM every nine weeks.
The conclusions showed that while pemetrexed was well tolerated in this patient population, it was not active. Most adverse events were related to disease state, not study treatment.
Phase II study of gemcitabine plus zoledronic acid in subjects with Stage IV pancreatic cancer
Researchers: Thomas Cartwright, M.D., Ocala Oncology; John Cox, D.O., Texas Cancer Center, Dallas Southwest; Marcus Neubauer, M.D., Kansas City Cancer Centers, Southwest; David McCollum, M.D., Sammons Cancer Center, Dallas; John Sandbach, M.D., Texas Oncology Cancer Center, Balcones; Michael A. Monticelli, M.D., Williamette Valley Cancer Center, Springfield; Kristi A. Boehm, M.S., US Oncology Research; Des Ilegbodu, Dr.PH., US Oncology Research; Lina Asmar, Ph.D., US Oncology Research
According to the researchers, Gemcitabine, the standard chemotherapy for advanced pancreatic cancer (APC), produces low response rates and short time to progression. Preclinical studies suggested that zoledronic acid inhibits pancreatic cell lines by interfering with the p21ras/raf-1/MEK1/ERKL signaling pathway. Researchers conducted this trial to evaluate the efficacy and toxicity of gemcitabine and zoledronic acid in subjects with APC.
Between December 2004 and July 2005, 35 subjects were enrolled. Baseline characteristics were: 20 males (57%), median age 66 years (range, 40-83), and KPS of 70/80/90/100 = 9%/29%/34%/29%, respectively. Four patients had locally advanced disease (three stage IIB and one stage III), 77% of subjects had Stage IV disease at diagnosis; 86% of subjects had adenocarcinoma. Prior therapy included surgery (n=14, 40%), chemotherapy (n=2, 6%), and radiotherapy (n=3, 9%).
Pancreatic cancer, typically advanced at diagnosis, remains a major treatment challenge. The research concluded that Zoledronic acid in combination with gemcitabine was well-tolerated in this study. Future genomic testing is proposed for responders.
Additional details on both presentations are available upon request from US Oncology.
About the US Oncology Research Network
The US Oncology Research Network is an established community-based research operation specializing in all phases of cancer clinical trials. The network currently has more than 520 physicians actively enrolling patients, and 88 regulatory sites, and is currently involved in approximately 77 research trials. The network has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the FDA for use. Since 1993, nearly 30,000 patients have participated in clinical trials managed by US Oncology network practices. For more information, visit the “Research” section under “Our Services” on the company’s Web site, http://www.usoncology.com .
About US Oncology, Inc.
US Oncology, headquartered in Houston, Texas, is one of the nation’s largest healthcare services networks dedicated exclusively to cancer treatment and research. US Oncology provides extensive services and support to its affiliated cancer care sites nationwide to help them expand their offering of the most advanced treatments and technologies, build integrated community- based cancer care centers, improve their therapeutic drug management programs, and participate in many of the new cancer-related clinical research studies. US Oncology is affiliated with 985 physicians operating in 494 locations, including 97 radiation oncology facilities in 33 states.
US Oncology, Inc.
CONTACT: Kimberly Rutherford of US Oncology, Inc., +1-832-601-6193, orkimberly.rutherford@usoncology.com ; or Elizabeth Vocke, +1-813-775-6206,or elizabeth.vocke@hillandknowlton.com , for US Oncology, Inc.
Web site: http://www.usoncology.com/
