Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Salivary Gland Cancer That Cannot Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine together with oxaliplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced or metastatic salivary gland cancer that cannot be removed by surgery.
|Study Design:||Masking: Open Label
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 [ Designated as safety issue: No ]
- Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment [ Designated as safety issue: No ]
- Toxicity as assessed by CTCAE weekly [ Designated as safety issue: Yes ]
- Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3 [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
- Determine the tumor response rate in patients with unresectable locally advanced or metastatic incurable salivary gland cancer treated with capecitabine and oxaliplatin.
- Determine time to disease progression in patients treated with this regimen.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a positive response after 2 courses receive additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of treatment beyond CR.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101075
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Robert I. Haddad, MD||Dana-Farber Cancer Institute|