Brief Summary

This phase II trial studies how well dasatinib works in treating patients with head and neck cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jul 2007

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

July 1, 2007

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

July 27, 2012

Completed

Last Updated

October 1, 2014

Status Verified

April 1, 2013

Enrollment Period

2.6 years

First QC Date

July 26, 2007

Results QC Date

April 18, 2012

Last Update Submit

September 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

Number of Participants With Progression-free Survival at 12-weeks
Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.
At 12-weeks

Study Arms (1)

Treatment (dasatinib)

EXPERIMENTAL

Patients receive dasatinib PO or via PEG tube BID. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: dasatinibProcedure: pharmacological studyProcedure: laboratory biomarker analysis

Interventions

dasatinibDRUG

Given PO or via PEG tube

Also known as: BMS-354825, Sprycel

Treatment (dasatinib)

pharmacological studyPROCEDURE

Correlative studies

Also known as: pharmacological studies

Treatment (dasatinib)

laboratory biomarker analysisPROCEDURE

Correlative studies

Treatment (dasatinib)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patient has histologically proven squamous cell carcinoma of the head and neck that is recurrent after surgery and/or radiation therapy or chemoradiation therapy or is metastatic and disease must be measurable by RECIST criteria
Patients must have measurable disease as defined by RECIST criteria
Patients have received =\< 1 prior chemotherapeutic regimen for recurrent or metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Leukocytes \>= 3,000/mcL
Absolute neutrophil count \>= 1,500/mcL
Platelets \>= 100,000/mcL
Hemoglobin (Hgb) \>= 9.0 g/dL
Total bilirubin =\< 1.5 X upper limit of normal
Albumin \>= 2.5 g/dL
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 1.5 X upper limit of normal
Creatinine =\< 3 mg/dl
Paraffin embedded tumor tissue that is appropriate for immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) analysis must be available or patient must be amenable to biopsy to obtain tissue for the study
Ability to understand and the willingness to sign a written informed consent document
Patient must not be pregnant or breastfeeding; all sexually active females of child-bearing potential and all sexually active males with sexual partners of child-bearing potential should practice contraception (e.g. barrier, hormonal, intrauterine device \[IUD\]) or sexual abstinence while in the study and for two months following completion of therapy
+2 more criteria

You may not qualify if:

Chemotherapy or palliative radiotherapy for recurrent and/or metastatic disease within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier; concomitant chemoradiation therapy within 6 weeks prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier
Other anti-neoplastic agents, i.e., cytotoxic chemotherapy, immunotherapy, radiotherapy or investigational therapy, used to treat the primary disease will not be allowed during the study; local radiation (excluding radiotherapy to the target lesion) for supportive reasons involving a small radiation field may be allowed
Patient has a history of uncontrolled or severe medical disease which could compromise participation in the study such as uncontrolled diabetes (fasting blood glucose \> 200 mg/dl), uncontrolled hypertension (systolic blood pressure \[BP\] \> 160 or diastolic BP \> 100 mmHg), severe infection (bacterial infection requiring intravenous \[IV\] antibiotics or human immunodeficiency virus \[HIV\]), angina at rest, congestive heart failure New York Heart Association (NYHA) class III or IV, ventricular arrhythmias requiring therapy, myocardial infarction within 6 months, \> grade 2 neuropathy
Patients may not be receiving any other investigational agents
Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; efforts should be made to switch patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications
Echocardiogram less than institutional normal measured by echocardiogram for subjects with history of congestive heart failure, symptoms of congestive heart failure, clinical evidence suggesting impaired cardiac function
Patients may not have any clinically significant cardiovascular disease including the following:
Myocardial infarction or ventricular tachyarrhythmia within 6 months
Prolonged correct QT interval (QTc) \> 480 msec (Fridericia correction)
Major conduction abnormality (unless a cardiac pacemaker is present)
Pregnant women and women who are currently breast-feeding may not participate in this study; all women of childbearing potential must have a negative pregnancy test within 72 hours prior to enrolling in the study; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Patients having pleural effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Salivary Gland NeoplasmsSquamous Cell Carcinoma of Head and NeckTongue Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeTongue Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title: Dr. Vassiliki Papadimitrakopoulou, Professor
Organization: MD Anderson Cancer Center

Study Officials

Vassiliki Papadimitrakopoulou
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 1, 2014

Results First Posted

July 27, 2012

Record last verified: 2013-04

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

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)

Study Arms (1)

Treatment (dasatinib)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations