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Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ezra Cohen, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00519077
First received: August 17, 2007
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to demonstrate the activity (response rate and rate of stable disease) of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).


Condition Intervention Phase
Head and Neck Neoplasms
 Drug: IRESSA® (gefitinib)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) as Monotherapy in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:

Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • response rate and rate of stable disease [ Time Frame: response rate - January 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: January 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: March 2005
Estimated Study Completion Date: May 2013
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: IRESSA® (gefitinib)
    250-mg oral dose-escalating dose; each patient will receive treatment at the dose that produces grade 2 skin toxicity until disease progression or withdrawal.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • squamous cell carcinoma of the head and neck
  • Tumour site that is amenable to biopsy. Patients can refuse biopsy and still participate in the study but all patients must have disease that can be biopsied
  • Aged 18 years or older
  • Prior EGFR-based therapy is allowed if greater than 4 months have elapsed since last dose of that agent and study entry
  • No chemotherapy or irradiation within the 28-day period preceding entry to the study.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Ability to understand and the willingness to sign a written informed consent document.
  • Normal organ and marrow function

Exclusion Criteria:

  • Known severe hypersensitivity to Iressa or any of the excipients of this product
  • Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia).
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
  • Pregnancy or breast feeding women
  • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
  • Any evidence of clinically active interstitial lung disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519077

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of Chicago
AstraZeneca
Investigators
Principal Investigator: Ezra EW Cohen, MD University of Chicago
  More Information

No publications provided

Responsible Party: Ezra Cohen, MD, Assistant Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00519077     History of Changes
Other Study ID Numbers: 13503A
Study First Received: August 17, 2007
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
cancer
squamous cell
carcinoma
head
neck

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
 Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013