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

Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial

Official title:

A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098631
• Other study ID #: NCI-2012-02636
• Secondary ID: NCI-2012-02636CD
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2004
• Last updated: January 6, 2014
• Start date: October 2004

Study information

• Verified date: January 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

PRIMARY OBJECTIVES:

I. Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with lapatinib.

II. Determine the progression-free survival, time to progression, and overall survival of patients treated with this drug.

III. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 cohorts according to prior epidermal growth factor receptor-targeted therapy (yes vs no).

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 40-88 patients (21-50 epidermal growth factor receptor [EGFR] inhibitor-naive patients [cohort A] and 19-38 EGFR inhibitor-pre-treated patients [cohort B]) will be accrued for this study within 4-12.6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

• Recurrent and/or metastatic disease

• Measurable disease

• At least 1 unidimensionally measurable lesion = 20 mm by conventional techniques OR = 10 mm by spiral CT scan

• No more than 2 prior treatment regimens for recurrent or metastatic disease

• Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemotherapy) is allowed and does not count as prior therapy for recurrent or metastatic disease

• No known brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• More than 3 months

• Bilirubin normal

• AST and ALT = 2.5 times upper limit of normal

• Creatinine normal

• Creatinine clearance > 60 mL/min

• Cardiac ejection fraction normal by echocardiogram or MUGA

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Able to swallow and retain oral or feeding tube-administered medication

• No malabsorption syndrome

• No requirement for IV alimentation

• No uncontrolled inflammatory gastrointestinal disease (e.g., Crohn's disease or ulcerative colitis)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib

• No other uncontrolled illness

• No active or ongoing infection

• No psychiatric illness or social situation that would preclude study compliance

• Prior cetuximab allowed

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No prior cumulative anthracycline therapy = 450 mg/m^2 of doxorubicin or equivalent

• More than 4 weeks since prior radiotherapy

• No prior surgical procedure affecting absorption

• Recovered from prior therapy

• Other prior epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib) allowed

• Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance in monitoring INR

• No concurrent CYP3A4 inhibitors or inducers

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational agents

• No other concurrent anticancer therapy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Laryngeal Neoplasms
• Metastatic Squamous Neck Cancer With Occult Primary
• Nasopharyngeal Neoplasms
• Oropharyngeal Neoplasms
• Paranasal Sinus Neoplasms
• Recurrent Metastatic Squamous Neck Cancer With Occult Primary
• 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
• Salivary Gland Squamous Cell Carcinoma
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Larynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
• Untreated Metastatic Squamous Neck Cancer With Occult Primary

Intervention

Drug:
• lapatinib ditosylate
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate by RECIST	The 95% confidence intervals should be provided.	Up to 6 years	No
Primary	Progression-free survival (PFS)	Will be estimated using the Kaplan-Meier method.	From start of treatment to time of disease progression, assessed up to 6 years	No
Secondary	Overall survival	Will be estimated using the Kaplan-Meier method.	Up to 6 years	No
Secondary	Changes in EGFR, pEGFR, HER2	Paired t-tests or Wilcoxon signed rank tests will be performed to examine the magnitude and significance of pre-post treatment changes. To determine whether these markers are correlated with tumor response, both the baseline levels and the pre-post changes will be compared between responders and non-responders using the nonparametric, Wilcoxon rank-sum test. The correlative data will also be entered as covariates into a Cox regression model to determine whether they are predictive of progression-free and overall survival.	Baseline and 12 weeks	No
Secondary	Adverse events assessed using NCI CTCAE version 3.0	Adverse events will be summarized by type and grade.	Up to 6 years	Yes