Trial record 1 of 1 for:    vorinostat AND capecitabine AND neck AND nasopharynx
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Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01267240
First received: December 24, 2010
Last updated: September 16, 2014
Last verified: August 2014
  Purpose

This phase II trial is studying how well giving capecitabine with or without vorinostat works in treating patients with recurrent and/or metastatic head and neck cancer. 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.


Condition Intervention Phase
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Verrucous Carcinoma of the Larynx
Stage IV Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Drug: vorinostat
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Vorinostat and Capecitabine in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) and Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (complete and partial response) according to RECIST (Cohort A) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    95% confidence intervals will be provided for all interesting results.


Secondary Outcome Measures:
  • PFS (Cohort B) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method. 95% confidence intervals will be provided for all interesting results.


Estimated Enrollment: 145
Study Start Date: December 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (capecitabine)
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: capecitabine
Given orally
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda
Experimental: Arm II (vorinostat and capecitabine)
Patients receive oral vorinostat once daily and capecitabine as in arm I on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: vorinostat
Given orally
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza
Drug: capecitabine
Given orally
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda

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 SCCHN.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic SCCHN.

II. To determine the rate of progression-free survival (PFS) at 6 months. III. To determine the rate and duration of stable disease (SD). IV. To determine the median PFS, and the rate of PFS at 1 year. V. To determine the median overall survival (OS), and rates of overall survival at 6 months and at 1 year.

OUTLINE: This is a multicenter, open-label study of patients with squamous cell carcinoma of the head and neck followed by a randomized study of patients with nasopharyngeal carcinoma (NPC).

Patients receive oral capecitabine twice daily and oral vorinostat once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with complete response may receive two additional courses. Patients with NPC are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral capecitabine twice daily on days 1-14.

ARM II: Patients receive oral vorinostat once daily and capecitabine as in arm I on days 1-14.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients will be followed up every 6 months for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed disease meeting 1 of the following criteria:

    • Squamous cell carcinoma of the head and neck (SCCHN)

      • Oral cavity
      • Oropharynx
      • Larynx
      • Hypopharynx
      • Paranasal sinus
      • SCCHN of unknown origin must be reviewed and approved by principal investigator
    • Nasopharyngeal carcinoma (NPC)
  • Patients with NPC must have completed one prior chemotherapy regimen for recurrent or metastatic disease at least 4 weeks prior to enrollment; in addition, they may have received prior systemic chemotherapy (ie, induction, concurrent or adjuvant) for NPC as part of the initial multimodality treatment for locally advanced disease if the chemotherapy is completed > 6 months prior to enrolment; patients are eligible if they received 5-FU as part of the initial multimodality treatment; patients are not eligible if they received capecitabine previously
  • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan

    • Indicator lesions must not have been previously treated with surgery, radiotherapy, or radio frequency ablation unless there is documented progression after therapy
  • No known brain metastases
  • ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
  • Life expectancy > 12 weeks
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (≤ 5 times ULN for patients with documented liver metastases)
  • Creatinine ≤ 1.25 times ULN OR creatinine clearance ≥ 50 mL/min
  • ECG with normal tracing or non-clinically significant changes that do not require medical intervention
  • QTc interval < 470 msec and without history of Torsade de Pointes or other symptomatic QTc abnormality
  • Not pregnant or nursing
  • Fertile patients must use effective contraception (abstinence or 2 birth control methods) prior to and for the duration of study
  • Willing and able to comply with schedule visits, treatment plan, laboratory tests, and other study procedures
  • More than 5 years since another malignancy except stage 0-IB cervical carcinoma, non-invasive basal cell or squamous cell skin carcinoma, or radically treated prostate cancer (prostatectomy or radiotherapy) with normal PSA and not requiring ongoing anti-androgen hormonal therapy

    • More than 10 years since malignant melanoma
  • No inability to take oral medications and/or a clinical or radiological diagnosis of bowel obstruction
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in this study
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Active peptic ulcer disease
    • Myocardial infarction within the past 6 months
    • Congestive heart failure
    • Symptomatic congestive heart failure
    • Active cardiomyopathy
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Uncontrolled hypertension
    • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • Not HIV positive
  • No known dihydropyrimidine dehydrogenase (DPD) deficiency
  • No concurrent radiotherapy (except for metastatic bone lesions)
  • At least 4 weeks since prior targeted therapy for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)

    • No prior or other concurrent histone deacetylase (HDAC) inhibitors (e.g., valproic acid)
  • More than 6 months since prior systemic chemotherapy (i.e., induction, concurrent, or adjuvant) as part of the initial multimodality treatment for locally advanced disease

    • No prior fluorouracil as part of initial modality treatment for patients with SCCHN
    • Prior fluorouracil for patients with nasopharyngeal carcinoma (NPC) allowed
    • No prior capecitabine for patients with SCCHN or NPC
  • At least 4 weeks since prior surgery or radiotherapy
  • Concurrent medication or substances known to affect or with the potential to affect the activity of vorinostat will be reviewed in a case by case by principal investigators
  • No other concurrent investigational agents
  • No concurrent medications that are generally accepted to have risk of causing Torsades de Pointes
  • No other concurrent anticancer therapy

    • Palliative interventions, such as paracentesis or palliative surgery, allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267240

Locations
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
City of Hope
Duarte, California, United States, 91010
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Veterans Administration Hospital - Martinez
Martinez, California, United States, 94553
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
City of Hope Medical Group Inc
Pasadena, California, United States, 91105
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
London Health Sciences Centre-Corporate
London, Ontario, Canada, N6A 4L6
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Investigators
Principal Investigator: Eric Chen University Health Network-Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01267240     History of Changes
Other Study ID Numbers: NCI-2011-02556, NCI-2011-02556, PMH-PHL-068, CDR0000689859, NCI 8192, PHL-068, 8192, N01CM00032, N01CM00038
Study First Received: December 24, 2010
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Nasopharyngeal Diseases
Capecitabine
Vorinostat
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Laryngeal Diseases
Laryngeal Neoplasms
Neoplasms, Unknown Primary
Oropharyngeal Neoplasms
Paranasal Sinus Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Neoplastic Processes
Nose Diseases
Nose Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Paranasal Sinus Diseases
Pathologic Processes
Pharyngeal Diseases
Pharyngeal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014