HOUSTON, June 5 /PRNewswire/ -- Preliminary findings from an investigator- initiated Phase II multicenter clinical study indicates that the combination of docetaxel and oxaliplatin is associated with good activity and manageable toxicity in patients with Stage IV gastroesophageal and/or stomach cancer.
The preliminary findings were presented by the principal investigator, Donald Richards, M.D., Ph.D., of Texas Oncology-Tyler Cancer Center and an affiliate of US Oncology, at the American Society of Clinical Oncologists (ASCO) Annual Meeting June 2-6 in Atlanta. US Oncology, Inc. is one of the nation's largest health care services networks focused on cancer treatment and research.
"We are very pleased with the results," said Dr. Richards. "This study shows response rates and overall survival equivalent to any of the front-line regimens currently available for gastric cancer. However, overall toxicity of the treatment is less than reported for many of the regimens. Overall these patients tolerated the treatment very well."
"We are delighted the study was accepted for presentation at this important conference and for the opportunity to share the results of our research with our peers."
The presentation:
Phase II multicenter trial of docetaxel+oxaliplatin in Stage IV gastroesophageal and/or stomach cancer patients
Researchers: Donald Richards, M.D., Ph.D., Texas Oncology-Tyler Cancer Center; Lalan Wilfong, M.D., Texas Oncology-Dallas Presbyterian; Douglas Reznick, M.D., Rocky Mountain Cancer Centers; David McCollum, M.D., Texas Oncology-Sammons Cancer Center; Kristi Boehm, M.S., Feng Zhan, Ph.D., and Lina Asmar, Ph.D., US Oncology Research.
The treatment of adenocarcinoma of the gastroesophageal junction/stomach (AGEJ/S) remains a therapeutic challenge.
A multicenter, Phase II study was conducted to explore the efficacy and safety profile of the combination of docetaxel+oxaliplatin in patients with previously untreated advanced AGEJ/S.
Docetaxel has shown significant single-agent activity and has recently been shown to increase response rates and overall survival when combined with cisplatin plus 5-FU. Oxaliplatin is associated with a more favorable safety profile compared to other platinum-based drugs (i.e., cisplatin).
Patients with metastatic (Stage IV) AGEJ/S were eligible. Docetaxel 60 mg/m2 IV over one hour was administered followed by oxaliplatin 130mg/m2 over two hours on day one of each 21-day cycle.
Patients were treated until disease progression or unacceptable toxicity; primary endpoints are response rate, toxicity, and progression free and overall survival.
According to the researchers, 70 subjects were enrolled. Baseline characteristics were: a median age of 59.4 years, 72 percent male patients, 76 percent white, and ECOG PS scores of 0/1/2 of 45%/49%/6%, respectively. 32.8 percent of patients had distal gastric cancer (fundus or pylorus). The median number of cycles delivered was 6 (range, 1-19). Thirty-nine patients (56 percent) have required dose reductions or delay, primarily due to neutropenia, thrombocytopenia, vomiting, neuropathy, and fatigue. Grade 3-4 toxicities include neutropenia (70 percent); leukopenia and vomiting (17 percent, each); nausea (16 percent); dehydration, fatigue, and diarrhea (13 percent, each), and thrombocytopenia and febrile neutropenia (7 percent, each). Sixty-six patients have completed greater than or equal to 2 cycles. The best overall confirmed response rate, by RECIST, was 23 PR (35.4 percent) for an overall response rate of 35.4 percent. Clinical benefit rate (CBR=CR+PR+SD greater than or equal to 6 months) was 42 percent. Median time to response was 1.3 months and median duration of response was 4.6 months. Median survival was 9.2 months and median PFS was 4.3 months.
The conclusions showed that the best overall response rate of 35 percent, CBR of 42 percent, and median survival of 9.2 months is encouraging and comparable to other standard front-line regimens.
Additional details on the ASCO presentation 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 research network currently has more than 520 physicians actively enrolling patients, 88 research sites, and is currently involved in 62 open research trials. The network has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the Food and Drug Administration 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 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. The network today consists of more than 1,000 physicians at nearly 500 locations in 34 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/