Spots Global Cancer Trial Database for Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Study Description

Brief Summary: This partially randomized phase II trial studies giving capecitabine and vorinostat in treating patients with head and neck cancer that has come back after previous treatment or that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine together with vorinostat is more effective than capecitabine alone in treating patients with cancer of the head and neck cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the objective response rate (complete and partial) and duration of response of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). (SCCHN) II. To determine the objective response rate (complete and partial) and duration of response of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic nasopharyngeal carcinoma (NPC). (NPC) SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic SCCHN. (SCCHN) II. To determine the rate of progression-free survival (PFS) at 6 months. (SCCHN) III. To determine the rate and duration of stable disease (SD). (SCCHN) IV. To determine the median PFS, and the rate of PFS at 1 year. (SCCHN) V. To determine the median overall survival (OS), and rates of overall survival at 6 months and at 1 year. (SCCHN) VI. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic NPC. (NPC) VII. To determine the duration of objective response. (NPC) VIII. To determine the rate and duration of stable disease (SD). (NPC) IX. To determine the median PFS, and the rate of PFS at 1 year. (NPC) X. To determine the median overall survival (OS), and rates of overall survival at 6 months and at 1 year. (NPC) OUTLINE: This is a non-randomized, open-label study of patients with SCCHN and NPC (Stage I), followed by a randomized study of patients with NPC (Stage II). STAGE I: Patients receive capecitabine orally (PO) twice daily (BID) and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. STAGE II: Patients with NPC are randomized to 1 of 2 treatment arms. ARM I: Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed up at 3-4 weeks and then every 6 months for 1 year.

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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