Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

NCT00114283 | Completed Phase 2

• 8 other identifiers: NCI-2011-03823HEAD AND NECK 04-3UVACC-33604CDR0000430924NCI-6697UVACC-HIC-115696697R21CA114986
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well lapatinib ditosylate works in treating patients with metastatic or recurrent head and neck cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Salivary Gland Cancer; 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; Salivary Gland Squamous Cell Carcinoma; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of antitumor activity as measured by objective response (CR+PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)

  Response will be classified by type and duration and 95% confidence intervals, adjusted for the interim looks, will be calculated.

  At least 6 months

Secondary Outcomes (3)

• Adverse events will be classified by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

  Up to 12 months

• Time to progression evaluated using the RECIST

  Time from start of treatment until disease progression or date of last follow-up, up to 12 months

• Changes in biochemical response as measured by biomarker data

  Up to 12 months

Study Arms (1)

Treatment (lapatinib ditosylate)

EXPERIMENTAL

Patients receive lapatinib ditosylate PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: lapatinib ditosylate; Other: laboratory biomarker analysis

Interventions

lapatinib ditosylate DRUG

Given PO

Also known as: GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

Treatment (lapatinib ditosylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (lapatinib ditosylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed metastatic or recurrent squamous cell carcinoma of the head/neck; these include tumors arising in the oral cavity, oropharynx, nasopharynx, hypopharynx, glottis, or ethmoid/maxillary sinus; patients with localized disease must have failed primary therapy radiotherapy, surgery, and/or chemotherapy); patients with single site or regional recurrence that, in view of the Principal Investigator (PI) or treating physician is potentially curable by resection or by re-irradiation program, must have declined such therapies
• 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; one or more sites of metastatic or recurrent disease must be accessible for needle biopsy
• No more than 2 prior chemotherapy regimens; no prior treatment with tyrosine kinase inhibitors or antibodies to the epidermal growth factor receptor (EGOR) or human epidermal growth factor receptor 2 (HER2)/neu; prior chemotherapy or radiation therapy completed at least 4 weeks prior to treatment with GW572016
• Life expectancy of greater than three months
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
• Leukocytes \> 3,000/uL
• Absolute neutrophil count \> 1,500/uL
• Platelets \> 100,000/uL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or multigated acquisition (MUGA) scan; note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution
• Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator; patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring international normalized ratio (INR); if medically appropriate and treatment available, the investigator may also consider switching these patients to low molecular weight (LMW) heparin, where an interaction with GW572016 is not expected
• The effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; 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

You may not qualify if:

• Prior treatment:
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or
• Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients who have had prior treatment with EGFR targeting therapies
• Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because GW572016 is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GW572016, breastfeeding should be discontinued if the mother is treated with GW572016; human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GW572016; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
• Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
• Concomitant requirement for medication classified as cytochrome P450 3A4 (CYP3A4) inducer or inhibitor

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Lapatinib; N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Tongue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christopher Thomas

  University of Virginia

  PRINCIPAL INVESTIGATOR

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: June 13, 2005
• First Posted: June 14, 2005
• Study Start: March 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: April 15, 2015

Record last verified: 2012-11

Locations

US (1)