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

April 14, 2015 updated by: National Cancer Institute (NCI)

Phase II Clinical Trial of AZD2171 Monotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Cediranib Maleate
Given orally
Other Names:
  • AZD2171
  • AZD2171 Maleate
  • Recentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response (complete response [CR], partial response [PR], progressive disease [PD], and stable disease [SD]) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame: Baseline to day 29
Compared using logistic regression.
Baseline to day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events, graded according to the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame: Up to 28 days after last dose of study treatment
Analyzed using binomial confidence intervals for these proportions.
Up to 28 days after last dose of study treatment
Distant metastasis
Time Frame: Every 2 courses until progression
Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.
Every 2 courses until progression
Overall survival
Time Frame: Up to 28 days after last dose of study treatment
Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.
Up to 28 days after last dose of study treatment
Progression-free survival
Time Frame: Up to 28 days after last dose of study treatment
Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.
Up to 28 days after last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: James Rocco, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 9, 2007

First Submitted That Met QC Criteria

April 9, 2007

First Posted (Estimate)

April 11, 2007

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-00148 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P30CA006516 (U.S. NIH Grant/Contract)
  • CDR0000538287
  • MGH-06-264
  • 06-264 (Other Identifier: Massachusetts General Hospital Cancer Center)
  • 7309 (CTEP)
  • R21CA119591 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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