AzTrials
AzTrials

Paranasal Sinus Squamous Cell CarcinomaPhase 2NCT01267240

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

A Phase 2 study testing Capecitabine and Vorinostat in people with Paranasal Sinus Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 14 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Capecitabine and Vorinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
14 sitesin 2 countries
Study dates
Dec 2010to Oct 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed SCCHN or NPC that is recurrent and/or metastatic and that is not amendable to curative therapy by surgery or radiation; SCCHN originating from the following sites are eligible: oral cavity, oropharynx, larynx, hypopharynx and paranasal sinus are eligible; for patients with a diagnosis of SCCHN of unknown origin, their eligibility must be reviewed and approved by the principal investigator
  • For patients with SCCHN, they may have received one prior targeted therapy for recurrent or metastatic disease (excluding histone deacetylase [HDAC] inhibitors) provided treatment is completed > 4 weeks prior to enrollment; they may have received prior systemic chemotherapy (ie, induction, concurrent or adjuvant) for SCCHN as part of the initial multimodality treatment for locally advanced disease if the chemotherapy is completed > 6 months prior to enrollment; patients are not eligible if they received fluorouracil (5-FU) or capecitabine previously as part of the initial multimodality treatment
  • 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 enrollment; patients are eligible if they received 5-FU as part of the initial multimodality treatment; patients are not eligible if they received capecitabine previously
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan; indicator lesions must not have been previously treated with surgery, radiation therapy or radiofrequency ablation unless there is documented progression after therapy
  • Patients must have completed any previous surgery or radiotherapy >= 4 weeks prior to enrollment
  • Previously treated patients must have evidence of progressive disease, either clinically or radiographically, as assessed by the investigator
Show all 19Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%)
  • Life expectancy of greater than 12 weeks
  • Absolute neutrophil count >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Total bilirubin =< 1.25 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN or =< 5 x ULN with documented liver metastases
  • Creatinine =< 1.25 x ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above 1.25 x ULN
  • 12-lead electrocardiogram (ECG) with normal tracing, or non-clinically significant changes that do not require medical intervention; corrected QT (QTc) interval < 470 msec, and without history of Torsades de Pointes or other symptomatic QTc abnormality
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity of vorinostat will be determined following review of their case by the principal investigator
  • Women of childbearing potential and men must be surgically sterilized, practicing abstinence, or agree to use 2 birth control methods prior to study entry and for the duration of study participation; the 2 birth control methods can be either be 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy; the following are considered adequate barrier methods of contraception: diaphragm or sponge, and condom; other methods of contraception such as copper intrauterine device or spermicide may be used; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
  • Willingness to discontinue taking any medications that are generally accepted to have a risk causing Torsades de Pointes during the study

Who cannot join

  • Past or current malignancy other than SCCHN or NPC, except for:
  • Cervical carcinoma Stage 1B or less
  • Non-invasive basal cell and squamous cell skin carcinoma
  • Malignant melanoma with a complete response of a duration of > 10 years
  • Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate specific antigen (PSA), and not requiring ongoing anti-androgen hormonal therapy
  • Other cancer diagnosis with a complete response of duration of > 5 years
Show all 16Show fewer
  • Patients may not be receiving any other investigational agents
  • Patients with known brain metastases should be excluded from this clinical trial
  • Prior use of capecitabine is not allowed
  • Prior and concomitant treatment with HDAC inhibitors (such as valproic acid) are not allowed
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in study
  • Patients who are unable to take oral medications and / or who have a clinical or radiological diagnosis of bowel obstruction are ineligible
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active peptic ulcer disease, myocardial infarction within 6 months prior to entry, congestive heart failure, symptomatic congestive heart failure, active cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with vorinostat
  • Human immunodeficiency virus (HIV)-positive patients are ineligible
  • Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency are excluded

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

United States9 sites

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Veterans Administration Hospital - Martinez

    Martinez, California, 94553

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • City of Hope South Pasadena

    South Pasadena, California, 91030

Other trials in United States

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre-Corporate

    London, Ontario, N6A 4L6

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • VorinostatDrug

    Also called L-001079038, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid

    Given PO

Study groups in NCT01267240
Study groupRoleWhat they receive
Arm I (capecitabine, vorinostat)ExperimentalPatients 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.
Receives: Drug: Capecitabine; Drug: Vorinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate According to Response Evaluation Criteria in Solid Tumors

    Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.

    Measured: Up to 1 year

Secondary outcomes (2)

  1. Survival

    Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  2. Progression-free Survival

    PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.

    Measured: From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJun 2015
  4. Study completionOct 2016

Why it stopped: Study treatment did not show clinical activity.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267240
Sponsor's protocol ID
NCI-2011-02556
Other IDs
NCI-2011-02556, PMH-PHL-068, CDR0000689859, NCI 8192, PHL-068, 8192, N01CM00032, N01CM00038
Status last verified
Mar 2017
First submitted
24 Dec 2010
Last updated
14 Apr 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Vorinostat in people with Paranasal Sinus Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate According to Response Evaluation Criteria in Solid Tumors (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in