To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
Summary
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Nasopharyngeal Cancer
Intervention
Zometa (zoledronic acid)
Location
SunYat-senU
GuangZhou
GuangDong
China
Status
Active, not recruiting
Source
Sun Yat-sen University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00697619
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Nasopharyngeal Neoplasms
Tumors or cancer of the NASOPHARYNX.
Seer Program
A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)
Nasopharyngeal Diseases
Pathological processes involving the NASOPHARYNX.
Human Bocavirus
A member of the family PARVOVIRIDAE, subfamily PARVOVIRINAE, originally isolated from human nasopharyngeal aspirates in patients with respiratory disease.
12-hydroxy-5,8,10,14-eicosatetraenoic Acid
A lipoxygenase metabolite of ARACHIDONIC ACID. It is a highly selective ligand used to label mu-opioid receptors in both membranes and tissue sections. The 12-S-HETE analog has been reported to augment tumor cell metastatic potential through activation of protein kinase C. (J Pharmacol Exp Ther 1995; 274(3):1545-51; J Natl Cancer Inst 1994; 86(15):1145-51)
Clinical Trials
Neoadjuvant Zoledronic Acid in Patients With Resectable Pancreas Cancer
The overall purpose of this research is to evaluate the safety and side effects of zoledronic acid (also known as Zometa) in patients before they have surgery to remove the cancer.
ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
To determine if therapy with Zometa® (zoledronic acid) 4mg will be effective in preventing the occurrence of bone metastases in prostate cancer patients at high risk of developing them. I...
Clinical trial in breast cancer patients with bone metastases pretreated with zoledronic acid. Looking at the effectiveness of giving zoledronic acid every 4 weeks versus every 12 weeks g...
The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1 mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth factor...
Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help...
PubMed Articles
To demonstrate the effect of zoledronic acid in proliferation, invasion, and migration of human nasopharyngeal carcinoma cell HNE-1 and explore the potential role of VEGF, MMP-2, and MMP-9 proteins in...
Background: The ABCSG-12 trial investigated the efficacy of gonadotropin-releasing hormone (GnRH)analogs in combination with tamoxifen or anastrozole +/- zoledronic acid (4 mg, q6m for 3 years) in 1,8...
Zoledronic Acid in the Treatment of Early-Stage Breast Cancer: Is There a Final Verdict?
Breast cancer, which preferentially metastasizes to bone, is the most common malignancy among women worldwide and is a leading cause of death. Clinical data from large, phase 3 trials (ie, ABCSG-12, Z...
Pharmacokinetics, pharmacodynamics, and safety of zoledronic acid in horses.
Objective-To determine the pharmacokinetics, pharmacodynamics, and safety of zoledronic acid in horses. Animals-8 healthy horses. Procedures-A single dose of zoledronic acid (0.057 mg/kg, IV) was admi...
BACKGROUND: Pamidronate and zoledronic acid are used for the prevention of skeletal-related events (SREs) in patients with advanced solid tumors, particularly breast and prostate cancers. There have b...