NCT00458978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2014

Enrollment Period

6.2 years

First QC Date

April 9, 2007

Last Update Submit

April 14, 2015

Conditions

Recurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Laryngeal Verrucous CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult PrimaryRecurrent Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaRecurrent Nasopharyngeal Keratinizing Squamous Cell CarcinomaRecurrent Oral Cavity Verrucous CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Salivary Gland CarcinomaSalivary Gland Squamous Cell CarcinomaSquamous Cell Carcinoma Metastatic in the Neck With Occult PrimaryStage IV Hypopharyngeal Squamous Cell CarcinomaStage IV Laryngeal Squamous Cell CarcinomaStage IV Laryngeal Verrucous CarcinomaStage IV Lip and Oral Cavity Squamous Cell CarcinomaStage IV Major Salivary Gland CarcinomaStage IV Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage IV Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage IV Oral Cavity Verrucous CarcinomaStage IV Oropharyngeal Squamous Cell CarcinomaTongue CarcinomaUntreated Metastatic Squamous Cell Carcinoma to Neck With Occult Primary

Outcome Measures

Primary Outcomes (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.

    Baseline to day 29

Secondary Outcomes (4)

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

    Up to 28 days after last dose of study treatment

  • Distant metastasis

    Every 2 courses until progression

  • Overall survival

    Up to 28 days after last dose of study treatment

  • Progression-free survival

    Up to 28 days after last dose of study treatment

Study Arms (1)

Treatment (enzyme inhibitor)

EXPERIMENTAL

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 MaleateOther: Laboratory Biomarker Analysis

Interventions

Cediranib MaleateDRUG

Given orally

Also known as: AZD2171, AZD2171 Maleate, Recentin
Treatment (enzyme inhibitor)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (enzyme inhibitor)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +44 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckLymphoid Interstitial PneumoniaSalivary Gland NeoplasmsTongue Neoplasms

Interventions

cediranib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesTongue Diseases

Study Officials

  • James Rocco

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2013

Study Completion

July 1, 2014

Last Updated

May 5, 2015

Record last verified: 2014-04

Locations

US(1)