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Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers
This study is ongoing, but not recruiting participants.
First Received: November 5, 2004   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095563
  Purpose

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

PURPOSE: Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers.


Condition Intervention Phase
Head and Neck Cancer
Drug: lapatinib ditosylate
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders Tonsils and Adenoids
Drug Information available for: Lapatinib Lapatinib Ditosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Lapatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma and Other Epidermal Growth Factor Receptor- and/or erbB2-Expressing Malignant Tumors of the Salivary Glands

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

Primary Outcome Measures:
  • Objective response rate (complete response and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response duration [ Designated as safety issue: No ]
  • Stable disease rate [ Designated as safety issue: No ]
  • Stable disease duration [ Designated as safety issue: No ]
  • Progression-free survival at 6 months and 1 year [ Designated as safety issue: No ]
  • Overall survival at 6 months and 1 year [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]

Study Start Date: November 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor activity of lapatinib, in terms of objective response rate (partial response [PR] and complete response [CR]), in patients with recurrent and/or metastatic adenoid cystic carcinoma of the salivary gland.

Secondary

  • Determine the duration of objective response in patients treated with this drug.
  • Determine the rate and duration of stable disease in patients treated with this drug.
  • Determine progression-free, median, and overall survival of patients treated with this drug.
  • Determine the antitumor activity of this drug, in terms of objective response rate (PR and CR), in patients with other epidermal growth factor receptor- and/or ERBB2-overexpressing malignant tumors of the salivary gland.
  • Determine the safety and tolerability of this drug in these patient populations.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

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

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 12-67 patients (12-37 patients with adenoid cystic carcinoma [ACC] of the salivary gland and a maximum of 30 patients with epidermal growth factor receptor- or ERBB2-expressing non-ACC of the salivary gland) will be accrued for this study within 18 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 adenoid cystic or other malignant salivary gland carcinoma of major or minor salivary gland origin, meeting 1 of the following criteria:

    • Epidermal growth factor receptor (EGFR) expressing tumors
    • ERBB2 expressing tumors
  • Recurrent and/or metastatic disease
  • Progressive disease as defined by 1 of the following criteria occurring within in the past 6 months:

    • At least a 20% increase in radiologically or clinically measurable disease
    • Appearance of any new lesions
    • Deterioration in clinical status
  • Not amenable to surgery or curative radiotherapy
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Lesion must be outside of field of prior local therapy OR disease has progressed within the treatment field
  • No symptomatic brain metastases

    • Patients with known brain metastases that have been stable ≥ 3 months since completion of radiotherapy or surgery and who have no significant neurological deficits and are off corticosteroids are eligible
  • Tumor lesions accessible for biopsy

    • In the event that tumor biopsy is medically contraindicated exceptions may be granted by the Principal Investigator only

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 12 weeks

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

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 medication
  • No gastrointestinal disease resulting in an inability to take oral 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
  • Willing and able to undergo tumor biopsy (unless medically contraindicated)
  • No other active malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib
  • No other uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy, except low-dose, non-myelosuppressive radiotherapy

Surgery

  • No prior gastrointestinal surgical procedures affecting absorption
  • At least 4 weeks since prior surgery

Other

  • Recovered from all prior therapy
  • No prior EGFR or ERBB2-targeting therapies
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors
  • At least 14 days since prior and no concurrent CYP3A4 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: NCT00095563

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Pennsylvania
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Lillian L. Siu, MD, FRCPC Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
Agulnik M, Cohen EW, Cohen RB, Chen EX, Vokes EE, Hotte SJ, Winquist E, Laurie S, Hayes DN, Dancey JE, Brown S, Pond GR, Lorimer I, Daneshmand M, Ho J, Tsao MS, Siu LL. Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. J Clin Oncol. 2007 Sep 1;25(25):3978-84.
Elser C, Tsao M, Pond G, et al.: Fluororescence in situ hybridization (FISH) gene amplification analysis of EGFR and HER2 in patients with malignant salivary gland tumors (MSGT) treated with lapatinib. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-C41, 2007.

Study ID Numbers: CDR0000394174, PMH-PHL-028, NCI-6701
Study First Received: November 5, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00095563     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
salivary gland adenoid cystic carcinoma
high-grade salivary gland mucoepidermoid carcinoma
salivary gland adenocarcinoma
salivary gland anaplastic carcinoma
salivary gland malignant mixed cell type tumor
salivary gland poorly differentiated carcinoma
salivary gland squamous cell carcinoma
low-grade salivary gland mucoepidermoid carcinoma
salivary gland acinic cell tumor
recurrent salivary gland cancer
stage IV salivary gland cancer

Study placed in the following topic categories:
Mouth Diseases
Lapatinib
Squamous Cell Carcinoma
Protein Kinase Inhibitors
Mouth Neoplasms
Recurrence
Oral Cancer
Carcinoma
Salivary Gland Neoplasms
Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Epidermoid Carcinoma
Mitogens
Adenoid Cystic Carcinoma
Stomatognathic Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Salivary Gland Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mouth Diseases
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Lapatinib
Protein Kinase Inhibitors
Mouth Neoplasms
Pharmacologic Actions
Salivary Gland Neoplasms
Carcinoma
Neoplasms
Neoplasms by Site
Carcinoma, Adenoid Cystic
Therapeutic Uses
Head and Neck Neoplasms
Stomatognathic Diseases
Adenocarcinoma
Salivary Gland Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009