Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
Overview
- Phase
- Phase 2
- Intervention
- Capecitabine
- Conditions
- Head and Neck Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
XELOX
* 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.
Intervention: Capecitabine
XELOX
* 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.
Intervention: Oxaliplatin
Outcomes
Primary Outcomes
Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
Time Frame: Every 2 Cycles
Secondary Outcomes
- 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)