Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

NCT ID: NCT00387335

Last Updated: 2014-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-03-31

Brief Summary

This phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer. 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.

Detailed Description

OBJECTIVES:

I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate.

II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B).

OUTLINE: This is 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.

Conditions

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

Given orally

Interventions

sunitinib malate

Given orally

Intervention Type: DRUG

Other Intervention Names

SU11248; sunitinib; Sutent

Eligibility Criteria

Inclusion Criteria

• History of class II heart failure and asymptomatic on treatment
• Prior anthracycline exposure
• Prior central thoracic radiation that included the heart in the radiotherapy port
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reactions to compounds of similar chemical or biological composition to sunitinib malate
• No history of serious ventricular arrhythmia (i.e., ventricular fibrillation or ventricular tachycardia >= 3 beats in a row)
• No history of other significant ECG abnormalities
• No uncontrolled hypertension (defined as systolic blood pressure [BP] >= 140 mm Hg or diastolic BP >= 90 mm Hg)
• No condition resulting in an inability to take oral medication, including any of the following:

• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• Active peptic ulcer disease
• No gastrostomy, jejunostomy, or other forms of enteral tube-feeding modalities
• No serious or nonhealing wound, ulcer, or bone fracture
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No cerebrovascular accident or transient ischemic attack within the past 12 months
• No myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
• No pulmonary embolism within the past 12 months
• No pre-existing uncontrolled thyroid abnormality (i.e., inability to maintain thyroid function within the normal range with medication)
• No uncontrolled intercurrent illness, including either of the following:

• Ongoing or active infection
• Psychiatric illness or social situation that would limit compliance with study requirement
• No more than two prior regimens for recurrent or metastatic disease:

• Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemoradiotherapy) is allowed and will not count as prior therapy for recurrent or metastatic disease
• At least 4 weeks since prior major surgery
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• At least 4 weeks since prior radiotherapy
• No prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, or VEGF Trap)
• No prior surgical procedure affecting absorption
• At least 7 days since prior and no concurrent use of CYP3A4 inhibitors, including any of the following:

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

• Rifampin
• Phenytoin
• Rifabutin
• Hypericum perforatum (St. John's wort)
• Carbamazepine
• Efavirenz
• Phenobarbital
• Tipranavir
• No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin):

Concurrent dosing of =< 2 mg of warfarin daily for prophylaxis of thrombosis is allowed; Concurrent low molecular weight heparin allowed provided prothrombin time INR is =< 1.5

• No other concurrent investigational agents
• No concurrent agents with proarrhythmic potential, including any of the following:

• Terfenadine
• Quinidine
• Procainamide
• Disopyramide
• Sotalol
• Probucol
• Bepridil
• Haloperidol
• Risperidone
• Indapamide
• Flecainide
• No other concurrent anticancer agents or therapies
• No concurrent combination antiretroviral therapy for HIV-positive patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ezra Cohen

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2009-00214

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000504024

Identifier Type: -

Identifier Source: secondary_id

7738

Identifier Type: OTHER

Identifier Source: secondary_id

7738

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA014599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00214

Identifier Type: -

Identifier Source: org_study_id