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

NCT00519077 | Completed Phase 2 Results DMC

• 1 other identifier: 13503A
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Head and Neck Neoplasms

Keywords

cancer; squamous cell; carcinoma; head; neck

Outcome Measures

Primary Outcomes (1)

• Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates

  The proportion of subjects that responded \[complete (CR) or partial response (PR)\], had stable disease (SD), or progressive disease (PD) as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

  8 weeks

Secondary Outcomes (1)

• Median Progression-free Survival Time

  9 months

Study Arms (1)

Gefitinib

EXPERIMENTAL

Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.

Drug: Gefitinib

Interventions

Gefitinib DRUG

Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.

Also known as: IRESSA®

Gefitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 epidermal growth factor receptor (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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• AstraZeneca: collaborator

Study Sites (2)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Perez CA, Song H, Raez LE, Agulnik M, Grushko TA, Dekker A, Stenson K, Blair EA, Olopade OI, Seiwert TY, Vokes EE, Cohen EE. Phase II study of gefitinib adaptive dose escalation to skin toxicity in recurrent or metastatic squamous cell carcinoma of the head and neck. Oral Oncol. 2012 Sep;48(9):887-92. doi: 10.1016/j.oraloncology.2012.03.020. Epub 2012 Apr 17.

  PMID: 22513208 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms; Carcinoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Tanguy Lim-Seiwert
• Organization: The University of Chicago

seiwert@uchicago.edu

773-702-2452

Study Officials

• Ezra EW Cohen, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 21, 2007
• Study Start: March 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2013
• Last Updated: July 1, 2016
• Results First Posted: November 21, 2013

Record last verified: 2016-06

Locations

US (2)