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

National Cancer Institute (NCI)1 site in 1 country30 target enrollmentMarch 2005

Interventionslapatinib ditosylate laboratory biomarker analysis

Drugslapatinib ditosylate

Overview

Phase: Phase 2
Intervention: lapatinib ditosylate
Conditions: Recurrent Salivary Gland Cancer
Sponsor: National Cancer Institute (NCI)
Enrollment: 30
Locations: 1
Primary Endpoint: Evaluation of antitumor activity as measured by objective response (CR+PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

October 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Institute (NCI)

Responsible Party

Sponsor

Eligibility Criteria

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

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)

Arms & Interventions

Treatment (lapatinib ditosylate)

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

Intervention: lapatinib ditosylate

Treatment (lapatinib ditosylate)

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

Intervention: laboratory biomarker analysis

Outcomes

Primary Outcomes

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

Time Frame: At least 6 months

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

Secondary Outcomes

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)