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: April 9, 2014
Last verified: April 2014

April 9, 2007
April 9, 2014
February 2007
May 2013   (final data collection date for primary outcome measure)
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.
Tumor response
Complete list of historical versions of study NCT00458978 on ClinicalTrials.gov Archive Site
  • 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.
  • Overall survival
  • Progression-free survival
  • Distant metastasis
  • Adverse event rate
Not Provided
Not Provided
 
Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Given orally
    Other Names:
    • AZD2171
    • Recentin
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: cediranib maleate
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
19
Not Provided
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00458978
NCI-2009-00148, NCI-2009-00148, CDR0000538287, MGH-06-264, 06-264, 7309, P30CA006516, R21CA119591
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: James Rocco Massachusetts General Hospital
National Cancer Institute (NCI)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP