Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer

NCT ID: NCT00458978

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2014-07-31

Brief Summary

This phase II trial is studying how well cediranib maleate works in treating patients with recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the objective clinical response in patients with recurrent or newly diagnosed metastatic squamous cell carcinoma of the head and neck treated with AZD2171 (cediranib maleate).

SECONDARY OBJECTIVES:

I. Determine the safety profile of this drug in these patients. II. Assess the early and late physiological and biological effects of this drug on tumor interstitial fluid pressure, pO2, and tumor microvasculature.

III. Assess the value of potential noninvasive biomarkers of response, including plasma levels of molecules involved in angiogenesis, circulating endothelial cells and progenitor cells, and functional imaging changes before and after treatment.

IV. Assess the gene expression patterns before and after treatment as predictors of clinical and biological response.

OUTLINE: This is a multicenter study.

Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo dynamic contrast-enhanced CT imaging and blood collection periodically during study for research studies assessing plasma levels of angiogenic/antiangiogenic molecules, circulating endothelial cells (by flow cytometry), progenitor cells, and protein analysis of potential biomarkers.

Conditions

Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Laryngeal Verrucous Carcinoma; Recurrent Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary; Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma; Recurrent Oral Cavity Verrucous Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Recurrent Salivary Gland Carcinoma; Salivary Gland Squamous Cell Carcinoma; Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary; Stage IV Hypopharyngeal Squamous Cell Carcinoma; Stage IV Laryngeal Squamous Cell Carcinoma; Stage IV Laryngeal Verrucous Carcinoma; Stage IV Lip and Oral Cavity Squamous Cell Carcinoma; Stage IV Major Salivary Gland Carcinoma; Stage IV Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma; Stage IV Oral Cavity Verrucous Carcinoma; Stage IV Oropharyngeal Squamous Cell Carcinoma; Tongue Carcinoma; Untreated Metastatic Squamous Cell Carcinoma to Neck With Occult Primary

Study Design

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

Study Groups

Treatment (enzyme inhibitor)

Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Cediranib Maleate

Intervention Type: DRUG

Given orally

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Cediranib Maleate

Given orally

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

AZD2171; AZD2171 Maleate; Recentin

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed squamous cell carcinoma of the head and neck meeting one of the following criteria:

• Recurrent disease

• Previously treated with standard curative therapy, including surgery and/or radiotherapy with or without chemotherapy
• Newly diagnosed metastatic disease
• Must be deemed incurable by all of the following:

• Salvage surgery
• Radiotherapy
• Measurable disease ≥ 1 cm by conventional techniques, flexible fiberoptic laryngoscopy, or examination under anesthesia
• No more than 2 prior conventional or investigational systemic therapies for categorically incurable local-regional or distant disease
• No known primary brain tumor or brain metastases
• ECOG performance status 0-1
• Life expectancy ≥ 6 months
• WBC > 3,000/mm³
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³
• Hemoglobin > 8 g/dL
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance > 60 mL/min
• Proteinuria ≤ +1 on 2 consecutive urine dipsticks taken ≥ 1 week apart
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• History of nonmelanoma skin cancer or other prior malignancy allowed provided the cancer has been in remission for > 3 years
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to AZD2171
• No hypertension (i.e., systolic blood pressure (BP) > 160 mm Hg and diastolic BP > 100 mm Hg)
• No history of hypertensive urgency, hypertensive emergency, or end-organ damage (i.e., thrombotic stroke, transient ischemic attacks, intracerebral hemorrhage, myocardial infarction, aortic aneurysm, or aortic dissection)
• QTc ≤ 500 msec (with Bazett's correction)
• No history of familial long QT syndrome
• No concurrent uncontrolled illness including, but not limited to, any of the following:

• Bleeding diathesis
• Congestive heart failure, defined as New York Heart Association (NYHA) class III-IV congestive heart failure

• NYHA class II congestive heart failure allowed provided there is increased monitoring
• Significant ECG abnormality
• Peripheral vascular disease
• Unstable angina pectoris
• Cardiac arrhythmia
• Pulmonary edema
• Atrioventricular (AV) conduction abnormalities
• Sick sinus syndrome
• Second- or third-degree AV block
• Deep venous thrombosis
• No nonhealing ulcers, bone fracture, or wounds
• No psychiatric illness or social situation that would preclude study compliance
• No traumatic injury within the past 7 days
• No known coagulopathy that increases risk of bleeding
• No history of clinically significant hemorrhages
• See Disease Characteristics
• Recovered from all prior therapies
• No prior antiangiogenic therapy
• No more than 2 prior chemotherapy or antineoplastic regimens for categorically incurable local-regional or distant disease
• At least 4 weeks since prior radiotherapy or major surgery
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• More than 30 days since prior participation in an investigational trial
• No other concurrent investigational agents
• No concurrent drugs or biologics with proarrhythmic potential
• No concurrent anticoagulants (e.g., warfarin) or antiplatelet agents
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer agents or therapies

• 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

James Rocco

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

NCI-2009-00148

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000538287

Identifier Type: -

Identifier Source: secondary_id

MGH-06-264

Identifier Type: -

Identifier Source: secondary_id

06-264

Identifier Type: OTHER

Identifier Source: secondary_id

7309

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21CA119591

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00148

Identifier Type: -

Identifier Source: org_study_id