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Recurrent Hypopharyngeal Squamous Cell CarcinomaPhase 2NCT00458978

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

A Phase 2 study testing Cediranib Maleate and Laboratory Biomarker Analysis in people with Recurrent Hypopharyngeal Squamous Cell Carcinoma and Recurrent Laryngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cediranib Maleate and Laboratory Biomarker Analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Feb 2007to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 59Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Cediranib Maleate, Laboratory Biomarker Analysis
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Lymphoid Interstitial Pneumonia, Salivary Gland Neoplasms, Tongue Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cediranib MaleateDrug

    Also called AZD2171, AZD2171 Maleate, Recentin

    Given orally

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00458978
Study groupRoleWhat they receive
Treatment (enzyme inhibitor)ExperimentalPatients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cediranib Maleate; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Compared using logistic regression.

    Measured: Baseline to day 29

Secondary outcomes (4)

  1. Adverse events, graded according to the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Analyzed using binomial confidence intervals for these proportions.

    Measured: Up to 28 days after last dose of study treatment

  2. Distant metastasis

    Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.

    Measured: Every 2 courses until progression

  3. Overall survival

    Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.

    Measured: Up to 28 days after last dose of study treatment

  4. Progression-free survival

    Analyzed with binomial confidence intervals as well as Kaplan-Meier estimates for these proportions.

    Measured: Up to 28 days after last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionMay 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00458978
Sponsor's protocol ID
NCI-2009-00148
Other IDs
NCI-2009-00148, CDR0000538287, MGH-06-264, 06-264, 7309, P30CA006516, R21CA119591
Status last verified
Apr 2014
First submitted
9 Apr 2007
Last updated
5 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cediranib Maleate and Laboratory Biomarker Analysis in people with Recurrent Hypopharyngeal Squamous Cell Carcinoma and Recurrent Laryngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 59 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00458978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.

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