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

Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial

Official title:

Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387335
• Other study ID #: NCI-2009-00214
• Secondary ID: NCI-2009-00214CD
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2006
• Last updated: July 21, 2014
• Start date: August 2006
• Est. completion date: March 2010

Study information

• Verified date: December 2012
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Criteria:

• Hemoglobin >= 9 g/dL

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck:

• Recurrent and/or metastatic disease

• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques OR as >= 10 mm with spiral CT scan

• No known brain metastases

• Life expectancy >= 2 months

• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% (for patients in cohort A)

• ECOG PS 2 or Karnofsky PS 60-70% (for patients in cohort B)

• WBC >= 3,000/mm^3

• Absolute neutrophil count >= 1,500/mm^3

• Platelet count >= 100,000/mm^3

• Calcium =< 12.0 mg/dL

• Bilirubin normal

• AST and ALT =< 2.5 times upper limit of normal

• Creatinine normal OR creatinine clearance >= 60 mL/min

• QTc < 500 msec

• 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:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Laryngeal Neoplasms
• Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
• Nasopharyngeal Neoplasms
• Oropharyngeal Neoplasms
• Paranasal Sinus Neoplasms
• 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

Intervention

Drug:
• sunitinib malate
Given orally

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR	While patient remains on treatment, up to 30 weeks	No
Primary	Feasibility of Treatment	Ability to remain on treatment without dose reduction	While patient remains on treatment, up to 30 weeks	Yes
Secondary	Progression-free Survival	Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Up to 2 years	No
Secondary	Overall Survival	Time from start of treatment until death from any cause.	Up to two years	No