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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095563 |
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 |
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Head and Neck Cancer |
Drug: lapatinib ditosylate |
Phase II |
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 |
Study Start Date: | November 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Progressive disease as defined by 1 of the following criteria occurring within in the past 6 months:
Measurable disease
No symptomatic brain metastases
Tumor lesions accessible for biopsy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Principal Investigator: | Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada |
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 |
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 |
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 |
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 |