NCT01267240|TerminatedPhase 2ResultsDMC

Study Stopped

Study treatment did not show clinical activity.

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

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)

National Cancer Institute (NCI)ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

NCI-2011-02556

Secondary identifiers

NCI-2011-02556

REGISTRY · CTRP (Clinical Trial Reporting Program)

PMH-PHL-068

CDR0000689859

NCI 8192

PHL-068

OTHER · University Health Network-Princess Margaret Hospital

8192

OTHER · CTEP

N01CM00032

NIH

N01CM00038

NIH

Study Type

interventional

Actual enrollment (reported)

Locations

2 countries

Sites

Timeline

Study Start

December 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2015

Actual (reported)

Study Completion

October 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 25 participants
Study completion date: October 2016
Actual (reported)
Listed locations: 2 countries · 14 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 24, 2010
Actual (reported)
First Posted
December 28, 2010
Actual (reported)
Primary Completion
June 2015
Actual (reported)
Study Completion
October 2016
Actual (reported)
Results Posted
April 14, 2017
Actual (reported)

Last Updated: April 14, 2017
Status Verified: March 2017
Results QC Date: March 3, 2017
Last Update Submitted: March 3, 2017

Conditions

Paranasal Sinus Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
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
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
+4 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Arm I (capecitabine, vorinostat)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Arm I (capecitabine, vorinostat)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations