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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00458978
First received: April 9, 2007
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
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 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
Drug: cediranib maleate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of AZD2171 Monotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Compared using logistic regression.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 28 days after last dose of study treatment ] [ Designated as safety issue: No ]
    Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.

  • Progression-free survival [ Time Frame: Up to 28 days after last dose of study treatment ] [ Designated as safety issue: No ]
    Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.

  • Distant metastasis [ Time Frame: Every 2 courses until progression ] [ Designated as safety issue: No ]
    Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.

  • 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 ] [ Designated as safety issue: Yes ]
    Analyzed using binomial confidence intervals for these proportions.


Estimated Enrollment: 40
Study Start Date: February 2007
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: cediranib maleate
Given orally
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458978

Locations
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Investigators
Principal Investigator: James Rocco Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00458978     History of Changes
Other Study ID Numbers: NCI-2009-00148, NCI-2009-00148, CDR0000538287, MGH-06-264, 06-264, 7309, R21CA119591
Study First Received: April 9, 2007
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Diseases
Tongue Neoplasms
Carcinoma, Verrucous
Neoplasms, Unknown Primary
Salivary Gland Neoplasms
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Paranasal Sinus Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Salivary Gland Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms

ClinicalTrials.gov processed this record on April 14, 2014