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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00101075 |
Purpose
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.
| Condition | Intervention | Phase |
|
Head and Neck Cancer |
Drug: capecitabine Drug: oxaliplatin |
Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Salivary Gland Disorders |
| ChemIDplus related topics: | Capecitabine Oxaliplatin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers |
| Estimated Enrollment: | 33 |
| Study Start Date: | October 2004 |
OBJECTIVES:
Primary
Secondary
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed salivary gland cancer, including the following histologies:
Incurable disease
At least 1 unidimensionally measurable lesion documented by physical exam or radiology within the past month
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Massachusetts | |||||
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Dana-Farber Cancer Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Robert I. Haddad, MD | Dana-Farber Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000406025, DFCI-04149, SANOFI-DFCI-04149 |
| First Received: | January 7, 2005 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00101075 |
| Health Authority: | United States: Federal Government |
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