Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Part of paid clinical trials in Beverly Hills, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01267240
Phase
PHASE2
Status
Terminated

Conditions

  • Paranasal Sinus Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Stage IVA Hypopharyngeal Squamous Cell Carcinoma
  • Stage IVA Laryngeal Squamous Cell Carcinoma
  • Stage IVA Oral Cavity Squamous Cell Carcinoma
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma
  • Stage IVB Hypopharyngeal Squamous Cell Carcinoma
  • Stage IVB Laryngeal Squamous Cell Carcinoma
  • Stage IVB Oral Cavity Squamous Cell Carcinoma
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma
  • Stage IVC Hypopharyngeal Squamous Cell Carcinoma
  • Stage IVC Laryngeal Squamous Cell Carcinoma
  • Stage IVC Oral Cavity Squamous Cell Carcinoma
  • Stage IVC Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Given PO
  • Vorinostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Dec 31, 2010
Status verified
Mar 2017
Primary completion
Jun 30, 2015
Completion
Oct 31, 2016

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (capecitabine, vorinostat)
    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.

Primary Outcome Measure

Response Rate According to Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 1 year ]

Locations (9)

FacilityCityStateZIPSite coordinators
Tower Cancer Research FoundationBeverly HillsCalifornia90211-1850-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Contra Costa Regional Medical CenterMartinezCalifornia94553-3156-
Veterans Administration Hospital - MartinezMartinezCalifornia94553-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Beverly Hills, CA

By research site
Tower Cancer Research Foundation· Beverly Hills, CACity of Hope Comprehensive Cancer Center· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAContra Costa Regional Medical Center· Martinez, CAVeterans Administration Hospital - Martinez· Martinez, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CA

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