Title XELOX FOR SALIVARY GLAND CANCERS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00101075|
Recruitment Status : Terminated (Slow Accrual)
First Posted : January 10, 2005
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Capecitabine Drug: Oxaliplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2008|
Other Name: XelodaDrug: Oxaliplatin
Other Name: Eloxatin
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101075
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Robert I. Haddad, MD||Dana-Farber Cancer Institute|