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

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ClinicalTrials.gov Identifier: NCT00098631
Recruitment Status : Completed
First Posted : December 8, 2004
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: lapatinib ditosylate Other: laboratory biomarker analysis Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
Study Start Date : October 2004
Actual Primary Completion Date : December 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: lapatinib ditosylate
Given orally

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate by RECIST [ Time Frame: Up to 6 years ]
    The 95% confidence intervals should be provided.

  2. Progression-free survival (PFS) [ Time Frame: From start of treatment to time of disease progression, assessed up to 6 years ]
    Will be estimated using the Kaplan-Meier method.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 6 years ]
    Will be estimated using the Kaplan-Meier method.

  2. Changes in EGFR, pEGFR, HER2 [ Time Frame: Baseline and 12 weeks ]
    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.

  3. Adverse events assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 6 years ]
    Adverse events will be summarized by type and grade.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098631


Locations
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United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ezra Cohen University of Chicago Comprehensive Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098631    
Other Study ID Numbers: NCI-2012-02636
NCI-2012-02636 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000398163
UCCRC-13394
NCI-6718
13394A ( Other Identifier: University of Chicago Comprehensive Cancer Center )
6718 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2004    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Carcinoma
Paranasal Sinus Neoplasms
Neoplasms, Unknown Primary
Laryngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Respiratory Tract Neoplasms
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Nasopharyngeal Neoplasms
Nasopharyngeal Diseases
Nose Neoplasms
Nose Diseases
Paranasal Sinus Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Lapatinib