Title XELOX FOR SALIVARY GLAND CANCERS

Phase 2

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Drug: Capecitabine; Drug: Oxaliplatin

• Registration Number: NCT00101075
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The goal of this clinical research study is to find out how effective oxaliplatin and capecitabine are against advanced cancer of the salivary gland. The safety of this treatment as well as how long the cancer responds or stays in a stable state due to the treatment will also be studied.

Detailed Description

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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-01-07
• Study First Submitted QC: 2005-01-07
• Study First Posted: 2005-01-10
• Primary Completion: 2007-03
• Study Completion: 2008-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XELOX	Capecitabine	* Oxaliplatin 130 mg/m2 day 1 every 3 weeks * Capecitabine 1700 mg/m2/day days 1-14 every 3 weeks. -- Patients will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.
XELOX	Oxaliplatin	* Oxaliplatin 130 mg/m2 day 1 every 3 weeks * Capecitabine 1700 mg/m2/day days 1-14 every 3 weeks. -- Patients will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.

Primary Outcome Measures

Name	Time	Method
Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment	Every 2 Cycles

Secondary Outcome Measures

Name	Time	Method
Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment	Every 2 Cycles
Toxicity as assessed by CTCAE weekly	Weekly
Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3	Baseline andDay 3

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States