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Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2 Trial of GW572016 in Patients With Metastatic and Recurrent Squamous Cell Carcinomas of the Head and Neck

NCT00114283•National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVES: I. The primary objective of this study is to estimate the objective response rate (complete response \[CR\] + partial response \[PR\]) in patients with squamous cell carcinomas of the head and neck following treatment with GW572016 (lapatinib ditosylate). SECONDARY OBJECTIVES: I. Secondary objectives of this study are to estimate time to progression, describe the adverse event profile, and to obtain preliminary assessments of changes in pre- versus post-treatment measurements for selected biomarkers in tumor cells from these patients. OUTLINE: Patients receive lapatinib ditosylate orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+6 more criteria

Exclusion Criteria

•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)
+1 more criteria

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Key Dates

Start Date

March 1, 2005

Primary Completion Date

October 1, 2006

Completion Date

October 1, 2006

Last Updated

April 15, 2015

Enrollment

ESTIMATED participants

Conditions

Recurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer

Interventions

lapatinib ditosylate

DRUG

laboratory biomarker analysis

OTHER

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

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