|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Chicago 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 |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| ChemIDplus related topics: | Lapatinib Lapatinib Ditosylate Salicylsalicylic acid Sodium salicylate |
| 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 | |||||
| University of Chicago |
| National Cancer Institute (NCI) |
| Study Chair: | Ezra Cohen, MD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000398163, UCCRC-13394A, NCI-6718 |
| First Received: | December 7, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00098631 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|