|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN) |
| Estimated Enrollment: | 88 |
| Study Start Date: | November 2004 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
Measurable disease
No more than 2 prior treatment regimens for recurrent or metastatic disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80010 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| 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 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615-7828 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Fort Wayne Medical Oncology and Hematology | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| 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 | |
| Study Chair: | Ezra Cohen, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000398163, UCCRC-13394, NCI-6718 |
| Study First Received: | December 7, 2004 |
| Last Updated: | April 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098631 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lapatinib Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |