| ||||
| ||||
SU5416 Inhibits Growth and Spread of Colorectal Cancer, Early Study Shows
by Rosemarie Foster, BA, MA
Introduction
A novel angiogenesis inhibitor is showing promise for treating patients with metastatic colorectal cancer, reported investigators at the annual meeting of the American Society of Clinical Oncology in May 2000. Preliminary results from phase I/II clinical trials show that when the drug SU5416 is given to patients with untreated metastatic colorectal cancer, it may extend the time patients remain free of tumor growth and spread. The data also showed that SU5416 is well tolerated for at least one year when combined with 5-fluorouracil/leucovorin (5-FU/LV). SU5416 was developed by Sugen, a subsidiary of Pharmacia Corporation.How It Works
SU5416 inhibits angiogenesis by interfering with the communication channels between a cancerous tumor and healthy cells. By blocking the vascular endothelial growth factor receptor protein, SU5416 could block the ability of tumors to form blood vessels, thus depriving the tumor of nutrients necessary for growth and spread.Clinical Study Results
Dr. Lee Rosen, Assistant Professor and Director of the Cancer Therapy Development Program at UCLA, and colleagues evaluated 28 patients to determine the safety and efficacy of SU5416 when used in combination with 5-FU/LV. Patients with untreated advanced colorectal cancer were treated with increasing doses of SU5416 [85 mg/m(2) and 145 mg/m(2)] administered intravenously twice each week, in combination with standard doses of 5-FU/LV therapy. Patients receiving SU5416 were found to be free of tumor growth and spread for a median time in excess of 9.2 months. Of the 28 patients who participated in the study, data to date show 41% had an objective response (either complete or partial response with 50% or greater shrinkage of tumor size). A phase III clinical trial of 5FU/LV with and without SU5416 in metastatic colorectal cancer recently began.Pharmacia/Sugen is also conducting a pilot study to evaluate the safety of SU5416 in combination with Camptosar (irinotecan hydrochloride injection) and 5-FU/LV for the treatment of metastatic colorectal cancer. Pharmacia/Sugen is also researching oral forms of SU5416.
Adverse Events
Safety data showed no dose-limiting toxicity attributable to SU5416, with three patients remaining on therapy for more than one year. Toxicities seen to date are predominantly those known to occur with 5-FU/LV, including severe nausea, vomiting, diarrhea, mucositis, and neutropenia.
|
