Title XELOX FOR SALIVARY GLAND CANCERS
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers|
- Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment [ Time Frame: Every 2 Cycles ]
- Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment [ Time Frame: Every 2 Cycles ]
- Toxicity as assessed by CTCAE weekly [ Time Frame: Weekly ]
- Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3 [ Time Frame: Baseline andDay 3 ]
|Study Start Date:||October 2004|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Other Name: XelodaDrug: Oxaliplatin
Other Name: Eloxatin
This is a study of two investigational agents called oxaliplatin and capecitabine.
Investigational agents have not received Food and Drug Administration (FDA) approval for the way they are being used in this study. This means an investigation drug is still under study to determine what a safe dose is, what the side effects are and whether or not it is effective in the disease or condition being studied.
Oxaliplatin and capecitabine are chemotherapy agents that have been approved by the FDA for use in other cancers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101075
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Robert I. Haddad, MD||Dana-Farber Cancer Institute|