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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00387335 |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma |
Estimated Enrollment: | 43 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This a multicenter, cohort study. Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 [cohort A] vs ECOG 2 [cohort B]).
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 1 year.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
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
PATIENT CHARACTERISTICS:
No New York Heart Association class III or IV heart failure
Patients with the following are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO/MUGA:
No condition resulting in an inability to take oral medication, including any of the following:
No uncontrolled intercurrent illness, including either of the following:
PRIOR CONCURRENT THERAPY:
No more than two prior regimens for recurrent or metastatic disease
At least 7 days since prior and no concurrent use of CYP3A4 inhibitors, including any of the following:
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)
No concurrent agents with proarrhythmic potential, including any of the following:
United States, Colorado | |
University of Colorado Cancer Center at UC Health Sciences Center | |
Aurora, Colorado, United States, 80045 | |
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 | |
Joliet Oncology-Hematology Associates, Limited - West | |
Joliet, Illinois, United States, 60435 | |
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, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Oncology Care Associates, PLLC | |
Saint Joseph, Michigan, United States, 49085 | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0942 | |
United States, Missouri | |
David C. Pratt Cancer Center at St. John's Mercy | |
Saint Louis, Missouri, United States, 63141 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 | |
Canada, British Columbia | |
British Columbia Cancer Agency - Vancouver Cancer Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Canada, Ontario | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Ottawa Hospital Regional Cancer Centre - General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Ezra Cohen, MD | University of Chicago |
Study ID Numbers: | CDR0000504024, UCCRC-14701A, NCI-7738 |
Study First Received: | October 12, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00387335 |
Health Authority: | United States: Food and Drug Administration |
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 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 metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary |
Squamous cell carcinoma Recurrence Carcinoma Epidermoid carcinoma Nasopharyngeal carcinoma Sunitinib Head and Neck Neoplasms |
Metastatic squamous neck cancer with occult primary Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |