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Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on December 7, 2004.   Last Updated on April 10, 2009   History of Changes
Sponsor: University of Chicago
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098631
  Purpose

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

PURPOSE: 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
Head and Neck Cancer
Drug: lapatinib ditosylate
Phase 2

Study Type: Interventional
Study Design: 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:
  • Response rate by RECIST at 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression at 8 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: November 2004
Detailed Description:

OBJECTIVES:

  • Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with lapatinib.
  • Determine the progression-free survival, time to progression, and overall survival of patients treated with this drug.
  • 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-naïve 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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • Cardiac ejection fraction normal by echocardiogram or MUGA
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Gastrointestinal

  • 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)

Other

  • 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 CONCURRENT THERAPY:

Biologic therapy

  • Prior cetuximab allowed

Chemotherapy

  • 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

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • No prior surgical procedure affecting absorption

Other

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

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Ezra Cohen, MD University of Chicago
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00098631     History of Changes
Other Study ID Numbers: CDR0000398163, UCCRC-13394, NCI-6718
Study First Received: December 7, 2004
Last Updated: April 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
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
metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
untreated metastatic squamous neck cancer with occult primary
salivary gland squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2012