Sunitinib, Cetuximab, and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
A Phase I Trial of Concurrent Chemoradiation/Chemoreirradiation With Cetuximab (ERBITUX®), Sunitinib, and Accelerated Radiation in Patients With Locally Advanced/High-risk/Recurrent Poor Prognosis Head and Neck Cancer
5 other identifiers
interventional
36
1 country
12
Brief Summary
This phase I trial is studying the side effects and best dose of sunitinib when given together with cetuximab and radiation therapy in treating patients with locally advanced or recurrent squamous cell carcinoma of the head and neck. 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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving sunitinib together with cetuximab and radiation therapy may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedJuly 2, 2013
July 1, 2013
4.2 years
May 20, 2009
July 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum-tolerated dose (MTD) of sunitinib malate
MTD is defined as the dose level immediately below the non-tolerated dose. The study will utilize a standard "3+3" design to determine the MTD. Dose limiting toxicities (DLTs) used for determining escalation of dose will be those occurring within the period of radiotherapy. Toxicity will be summarized by type and severity using the National Cancer Institute (NCI) Common Terminology Criteria.
Up to 7-9 weeks
Secondary Outcomes (7)
Objective tumor response rates
From the start of the treatment to up to 6 years
Locoregional control rates
Up to 6 years
Disease control rates
Up to 6 years
Locoregional recurrence rates
At 3 years
Time to progression
From the date of registration to the date of progressive disease or death from any cause
- +2 more secondary outcomes
Study Arms (1)
Treatment (enzyme inhibitor and monoclonal antibody therapy)
EXPERIMENTALPatients receive sunitinib malate orally or by percutaneous gastrostomy tube once daily, cetuximab IV over 60-120 minutes once weekly, and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 7-9 weeks in the absence of disease progression or unacceptable toxicity. Patients with persistent disease undergo surgical resection.
Interventions
Given orally or by percutaneous gastrostomy tube
Correlative studies
Undergo radiotherapy
Given IV
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, meeting any of the following criteria:
- Recurrent disease
- Second primary locoregional recurrence\* with no clinically measurable distant disease
- Poor prognosis non-metastatic head and neck carcinoma (M0)
- Must have undergone radiotherapy as a component of prior treatment
- Not a candidate for surgical resection with curative intent
- Patients with high-risk features at resection or following resection for recurrence are eligible
- Must have locoregional tumor amenable to radiotherapy or reirradiation with curative intent
- Entire gross tumor recurrence volume must be able to be treated without exceeding a cumulative spinal cord dose of 50 Gy
- Unresected tumors must be measurable according to RECIST
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 12 weeks
- WBC ≥ 3,000/mm\^³
- ANC \> 1,500/mm³
- +84 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 60702, United States
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
Fort Wayne, Indiana, 46845, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201-1595, United States
University of Michigan University Hospital
Ann Arbor, Michigan, 48109, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Villaflor
University of Chicago Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 21, 2009
Study Start
July 1, 2008
Primary Completion
September 1, 2012
Last Updated
July 2, 2013
Record last verified: 2013-07