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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098631
First received: December 7, 2004
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate by RECIST [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    The 95% confidence intervals should be provided.

  • Progression-free survival (PFS) [ Time Frame: From start of treatment to time of disease progression, assessed up to 6 years ] [ Designated as safety issue: No ]
    Will be estimated using the Kaplan-Meier method.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Will be estimated using the Kaplan-Meier method.

  • Changes in EGFR, pEGFR, HER2 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Adverse events assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
    Adverse events will be summarized by type and grade.


Estimated Enrollment: 88
Study Start Date: October 2004
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098631

Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Investigators
Principal Investigator: Ezra Cohen University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098631     History of Changes
Other Study ID Numbers: NCI-2012-02636, NCI-2012-02636, CDR0000398163, UCCRC-13394, NCI-6718, 13394A, 6718, N01CM62201, N01CM62209
Study First Received: December 7, 2004
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paranasal Sinus Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Diseases
Laryngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Unknown Primary
Oropharyngeal Neoplasms
Nasopharyngeal Diseases
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Neoplastic Processes
Nose Diseases
Nose Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Paranasal Sinus Diseases
Pathologic Processes
Pharyngeal Diseases
Pharyngeal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Stomatognathic Diseases
Lapatinib
Antineoplastic Agents

ClinicalTrials.gov processed this record on November 27, 2014