Phase 2
N=44
Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck
Head and Neck Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00519077 ↗Enrolled (actual)
44
Serious AEs
45.5%
Results posted
Nov 2013
Primary outcome: Primary: Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates — 6.81; 18.18; 75.00 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gefitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates |
6.81; 18.18; 75.00 | — |
| SECONDARY Median Progression-free Survival Time |
1.9 | — |
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).
Eligibility 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 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
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
Data sourced from ClinicalTrials.gov (NCT00519077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.