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

NCT ID: NCT00098631

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31

Brief 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.

Detailed 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.

Conditions

Metastatic Squamous Neck Cancer With Occult Primary; 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (lapatinib ditosylate)

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

Group Type: EXPERIMENTAL

lapatinib ditosylate

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

lapatinib ditosylate

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ezra Cohen

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Comprehensive Cancer Center

Locations

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2012-02636

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000398163

Identifier Type: -

Identifier Source: secondary_id

UCCRC-13394

Identifier Type: -

Identifier Source: secondary_id

NCI-6718

Identifier Type: -

Identifier Source: secondary_id

13394A

Identifier Type: OTHER

Identifier Source: secondary_id

6718

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02636

Identifier Type: -

Identifier Source: org_study_id