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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
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 |
| 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 | |
| Study Chair: | Robert I. Haddad, MD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000406025, DFCI-04149, SANOFI-DFCI-04149 |
| Study First Received: | January 7, 2005 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00101075 History of Changes |
| Health Authority: | United States: Federal Government |
|
high-grade salivary gland mucoepidermoid carcinoma low-grade salivary gland mucoepidermoid carcinoma salivary gland acinic cell tumor salivary gland adenocarcinoma salivary gland adenoid cystic carcinoma salivary gland malignant mixed cell type tumor |
salivary gland poorly differentiated carcinoma salivary gland squamous cell carcinoma recurrent salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer |
|
Antimetabolites Mouth Diseases Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mouth Neoplasms Pharmacologic Actions |
Salivary Gland Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Stomatognathic Diseases Salivary Gland Diseases |