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Sunitinib, Cetuximab, and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

Primary Purpose

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sunitinib malate
pharmacological study
3-dimensional conformal radiation therapy
cetuximab
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Platelet count > 100,000/mm³
  • Total bilirubin < 1.5 times upper limit of normal (ULN)
  • INR and PTT ratio < 1.5
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine normal OR creatinine clearance > 60 mL/min
  • Urine protein no more than trace
  • Hematocrit ≥ 28%
  • Hemoglobin ≥ 9 g/dL
  • QTc < 500 msec
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • The following patients are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO and MUGA:

    • Asymptomatic on treatment
    • Prior anthracycline exposure
    • Prior central thoracic radiotherapy included the heart in the radiotherapy port
  • No clinical evidence of active infection of any type, including hepatitis B or C virus

    • Infections controlled with therapy are allowed
    • Patients with hepatitis B or C on antiviral therapy with no detectable virus are allowed
  • No immune deficiency and/or HIV positivity
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
  • No gastrointestinal tract disease or condition, including any of the following, that impairs ability to retain sunitinib tablets:

    • Inability to take oral medication or a requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • None of the following conditions allowed:

    • Serious or nonhealing wound, ulcer, or bone fracture
    • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant concurrent medical or psychiatric illness which, in the opinion of the investigator, would interfere with the patient's ability to participate in the trial
  • No active carotid artery involvement
  • No history of documented thrombosis (pulmonary embolism within the past 12 months or deep vein thrombosis [DVT] within the past 6 months), known coagulopathies or thrombophilia, or evidence of DVT/thromboembolic event
  • No history of the following cardiovascular conditions :

    • Myocardial infarction within the past 12 months
    • Cardiac arrhythmia or serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia ≥ 3 beats in a row) within the past 12 months
    • Stable/unstable angina within the past 12 months
    • Symptomatic congestive heart failure within the past 12 months
    • Coronary/peripheral artery bypass graft or stenting within the past 12 months
    • No cerebral vascular disease, cerebrovascular accident (stroke), or transient ischemic attack within the past 6 months
    • QTc prolongation (QTc interval ≥ 500 msec)
    • New York Heart Association class III-IV congestive heart failure
    • Poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
    • Other significant ECG abnormalities
  • See Disease Characteristics
  • Recovered from all prior radiotherapy and chemotherapy
  • More than 4 months since prior radiotherapy to the head and neck
  • More than 2 weeks since prior hormone replacement therapy or hormonal contraceptives
  • More than 4 weeks since prior and no other concurrent investigational agents
  • At least 1 month since prior surgery (unless ambulatory within 48 hours)
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:

    • Azole antifungals (ketoconazole, itraconazole)
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Verapamil
    • HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
    • Delavirdine
  • At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • St. John wort
    • Efavirenz
    • Tipranavir
  • Concurrent coumarin-derivative anticoagulants (e.g., warfarin up to 2 mg daily) allowed for prophylaxis of thrombosis
  • Concurrent use of medications known to affect the conductive system (e.g., beta-blockers, calcium channel blockers, or digoxin) allowed under investigator supervision
  • No concurrent agent with proarrhythmic potential, including any of the following:

    • Terfenadine
    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Bepridil
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • No concurrent chronic steroid treatment for > 6 months (i.e., prednisolone doses > 10 mg/day or equivalent)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent amifostine
  • No concurrent commercial agent or therapy intended to treat head and neck cancer
  • No other concurrent anticancer therapy

Sites / Locations

  • University of Chicago Comprehensive Cancer Center
  • Decatur Memorial Hospital
  • Evanston CCOP-NorthShore University HealthSystem
  • Ingalls Memorial Hospital
  • Loyola University Medical Center
  • Illinois CancerCare-Peoria
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
  • University of Maryland Greenebaum Cancer Center
  • University of Michigan University Hospital
  • Saint John's Mercy Medical Center
  • Froedtert and the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (enzyme inhibitor and monoclonal antibody therapy)

Arm Description

Patients 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective tumor response rates
Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The efficacy analysis population (an exploratory analysis of those patients on study for the MTD) will consist of all subjects who received at least 1 dose of sunitinib. Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Locoregional control rates
Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Disease control rates
Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Locoregional recurrence rates
Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Time to progression
Time to progression using Kaplan-Meier product limit curves will be calculated.
Overall survival time
Overall survival using Kaplan-Meier product limit curves will be calculated.
Pharmacokinetics of sunitinib malate delivered by percutaneous gastrostomy tube

Full Information

First Posted
May 20, 2009
Last Updated
July 1, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00906360
Brief Title
Sunitinib, Cetuximab, and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety, the maximum tolerated dose, and the dose limiting toxicity of sunitinib malate when administered in combination with cetuximab and radiotherapy in patients with locally advanced, recurrent, or second primary poor prognosis, high-risk squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. To describe the toxicity profile of this regimen. II. To explore the tolerability and feasibility of sunitinib malate when administered in combination with cetuximab and radiotherapy in these patients. III. To assess the best overall response rate (complete and partial response) after completion of treatment. IV. To assess the locoregional control rate. V. To assess the distant control rate. VI. To assess the pharmacokinetics of sunitinib malate delivered by percutaneous gastrostomy tube. OUTLINE: This is a dose-escalation study of sunitinib malate. Patients 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. *NOTE: *Patients may have resection prior to enrollment on protocol provided they have high-risk features for recurrence. Some patients undergo blood sample collection at baseline and periodically during study for pharmacokinetic analysis of sunitinib malate and metabolites. After completion of study treatment, patients are followed up periodically for up to 6 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, 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, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Salivary Gland Cancer, 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, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity, Tongue Cancer, Untreated Metastatic Squamous Neck Cancer With Occult Primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (enzyme inhibitor and monoclonal antibody therapy)
Arm Type
Experimental
Arm Description
Patients 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.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
SU11248, sunitinib, Sutent
Intervention Description
Given orally or by percutaneous gastrostomy tube
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Other Intervention Name(s)
3D conformal radiation therapy, 3D-CRT
Intervention Description
Undergo radiotherapy
Intervention Type
Biological
Intervention Name(s)
cetuximab
Other Intervention Name(s)
C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Maximum-tolerated dose (MTD) of sunitinib malate
Description
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.
Time Frame
Up to 7-9 weeks
Secondary Outcome Measure Information:
Title
Objective tumor response rates
Description
Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The efficacy analysis population (an exploratory analysis of those patients on study for the MTD) will consist of all subjects who received at least 1 dose of sunitinib. Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Time Frame
From the start of the treatment to up to 6 years
Title
Locoregional control rates
Description
Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Time Frame
Up to 6 years
Title
Disease control rates
Description
Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Time Frame
Up to 6 years
Title
Locoregional recurrence rates
Description
Ninety percent confidence intervals using the exact binomial distribution will be presented. Kaplan-Meier product limit curves will be calculated.
Time Frame
At 3 years
Title
Time to progression
Description
Time to progression using Kaplan-Meier product limit curves will be calculated.
Time Frame
From the date of registration to the date of progressive disease or death from any cause
Title
Overall survival time
Description
Overall survival using Kaplan-Meier product limit curves will be calculated.
Time Frame
From the date of registration to the date of death or date of last patient contact if censored
Title
Pharmacokinetics of sunitinib malate delivered by percutaneous gastrostomy tube
Time Frame
Prior to and up to 24 hours after the start of sunitinib malate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Platelet count > 100,000/mm³ Total bilirubin < 1.5 times upper limit of normal (ULN) INR and PTT ratio < 1.5 AST and ALT ≤ 2.5 times ULN Creatinine normal OR creatinine clearance > 60 mL/min Urine protein no more than trace Hematocrit ≥ 28% Hemoglobin ≥ 9 g/dL QTc < 500 msec Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception The following patients are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO and MUGA: Asymptomatic on treatment Prior anthracycline exposure Prior central thoracic radiotherapy included the heart in the radiotherapy port No clinical evidence of active infection of any type, including hepatitis B or C virus Infections controlled with therapy are allowed Patients with hepatitis B or C on antiviral therapy with no detectable virus are allowed No immune deficiency and/or HIV positivity No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate No gastrointestinal tract disease or condition, including any of the following, that impairs ability to retain sunitinib tablets: Inability to take oral medication or a requirement for IV alimentation Prior surgical procedures affecting absorption Active peptic ulcer disease None of the following conditions allowed: Serious or nonhealing wound, ulcer, or bone fracture Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days No significant concurrent medical or psychiatric illness which, in the opinion of the investigator, would interfere with the patient's ability to participate in the trial No active carotid artery involvement No history of documented thrombosis (pulmonary embolism within the past 12 months or deep vein thrombosis [DVT] within the past 6 months), known coagulopathies or thrombophilia, or evidence of DVT/thromboembolic event No history of the following cardiovascular conditions : Myocardial infarction within the past 12 months Cardiac arrhythmia or serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia ≥ 3 beats in a row) within the past 12 months Stable/unstable angina within the past 12 months Symptomatic congestive heart failure within the past 12 months Coronary/peripheral artery bypass graft or stenting within the past 12 months No cerebral vascular disease, cerebrovascular accident (stroke), or transient ischemic attack within the past 6 months QTc prolongation (QTc interval ≥ 500 msec) New York Heart Association class III-IV congestive heart failure Poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg) Other significant ECG abnormalities See Disease Characteristics Recovered from all prior radiotherapy and chemotherapy More than 4 months since prior radiotherapy to the head and neck More than 2 weeks since prior hormone replacement therapy or hormonal contraceptives More than 4 weeks since prior and no other concurrent investigational agents At least 1 month since prior surgery (unless ambulatory within 48 hours) At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: Azole antifungals (ketoconazole, itraconazole) Clarithromycin Erythromycin Diltiazem Verapamil HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir) Delavirdine At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following: Rifampin Rifabutin Carbamazepine Phenobarbital Phenytoin St. John wort Efavirenz Tipranavir Concurrent coumarin-derivative anticoagulants (e.g., warfarin up to 2 mg daily) allowed for prophylaxis of thrombosis Concurrent use of medications known to affect the conductive system (e.g., beta-blockers, calcium channel blockers, or digoxin) allowed under investigator supervision No concurrent agent with proarrhythmic potential, including any of the following: Terfenadine Quinidine Procainamide Disopyramide Sotalol Probucol Bepridil Haloperidol Risperidone Indapamide Flecainide No concurrent chronic steroid treatment for > 6 months (i.e., prednisolone doses > 10 mg/day or equivalent) No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent amifostine No concurrent commercial agent or therapy intended to treat head and neck cancer No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Villaflor
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston CCOP-NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
60702
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
University of Michigan University Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Saint John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Froedtert and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Sunitinib, Cetuximab, and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

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