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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095901 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have locally recurrent or metastatic nasopharyngeal cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma |
Study Start Date: | June 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the nasopharynx
The following primary tumor sites or types are excluded:
Received at least 1, but no more than 2, prior chemotherapy regimens for recurrent locoregional or metastatic disease
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Neurologic
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 |
Study Chair: | Lori J. Wirth, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000393550, DFCI-03384 |
Study First Received: | November 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00095901 History of Changes |
Health Authority: | United States: Federal Government |
recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx |
Antimetabolites Capecitabine Nasopharyngeal Carcinoma Head and Neck Neoplasms Epidermoid Carcinoma |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Recurrence Carcinoma |
Antimetabolites Capecitabine Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Head and Neck Neoplasms Pharmacologic Actions |