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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate and rate of stable disease

Outcome Time Frame:

response rate - January 2008

Safety Issue:

No

Principal Investigator

Ezra EW Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

13503A

NCT ID:

NCT00519077

Start Date:

March 2005

Completion Date:

May 2013

Related Keywords:

  • Head and Neck Neoplasms
  • cancer
  • squamous cell
  • carcinoma
  • head
  • neck
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Northwestern UniversityChicago, Illinois  60611