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A Phase II Study of ZD1839 and Radiation in Patients With Squamous Cell Carcinoma of the Skin

Phase 2
18 Years
Open (Enrolling)
Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin

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Trial Information

A Phase II Study of ZD1839 and Radiation in Patients With Squamous Cell Carcinoma of the Skin


I. Early progression rate (progression during ZD1839 induction). II. Feasibility of
induction ZD1839 (for all patients) and concomitant ZD1839 with radiotherapy (for
unresectable patients).

III. Toxicities of induction ZD1839 (for all patients) and concomitant ZD1839 with
radiotherapy (for unresectable patients).


I. Response: clinical responses to induction therapy. II. Failures: frequency and timing of
local and distant failures. III. Biomarkers: biomarker levels in tumor and normal tissue.


I. For progressive disease responders, patients will be followed for locoregional and
distant metastases data.

II. Feasibility of maintenance ZD1839. III. Toxicities of maintenance ZD1839.

OUTLINE: Patients are assigned to 1 of 2 groups.

STRATUM I (initially resectable tumor): Patients undergo radiotherapy once daily (QD) 5 days
a week for approximately 6-7 weeks. Patients also receive gefitinib orally (PO) QD for up to
12 months

STRATUM II (initially unresectable tumor): Patients undergo radiotherapy QD 5 days a week
for approximately 6-7 weeks. Patients also receive concurrent gefitinib PO QD for 6-7 weeks.
Patients then undergo surgery. After surgery, patients receive gefitinib PO QD for up to 12

After completion of study treatment, patients are followed up for up to 5 years.

Inclusion Criteria:

- Within 12 weeks (+/- 2 weeks) prior to study entry, patients must have histologically
or cytologically confirmed squamous cell carcinoma (SCC) of skin that is either
locally advanced or recurrent with measurable disease; if the biopsy was collected
outside of MDACC, the MDACC Pathology Department must assess and confirm the SCC

- Patients may have previous surgical intervention with residual or recurrent disease

- ECOG performance status =< 2 (Karnofsky >= 60%)

- Leukocytes >= 3,000/mm^3

- Absolute neutrophil count >= 1,500/mm^3

- Platelets >= 100,000/mm*3

- Total bilirubin within normal institutional limits

- AST (SGOT) and ALT (SGPT) =< 2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits OR; creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Tumors must be at least 2 cms in size or have histological or cytological
verification of muscle, bone, lymph node metastasis, or perineural involvement, as
measured by the treating physician(s) or National PI

- Negative serum pregnancy test for women of child-bearing potential (performed within
14 days, +/- 1 day, prior to start of treatment); women of child-bearing potential
and men must agree to use adequate contraception prior to study entry and for the
duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in the study, she should inform her treating
physician(s) immediately

- Ability to understand and the willingness to sign a written Informed Consent Document
(ICD); in the event that non-English speaking participants are eligible for this
study, a short form (if applicable) or an ICD in their language, will be utilized and
completed in accordance with the MDACC "Policy For Consenting Non-English Speaking

Exclusion Criteria:

- Patients who have previous radiotherapy to the proposed site of skin cancer

- Patients with active cancers other than skin

- Patients currently receiving any other investigational agents at time of study
enrollment; patients may have received investigational agents in the past; no washout
time period is required

- Patients with a history of brain metastases must be excluded from this clinical study
because of their poor prognosis and because they often develop progressive
neurological dysfunction that would confound the evaluation of neurological and other
adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ZD1839

- Age less than 18 years

- Presence of uncontrolled intercurrent illness (co-morbid conditions) that would limit
compliance with study requirements including , but not limited to, ongoing or active
infection requiring parenteral antibiotics at time of study registration, symptomatic
congestive heart failure (NYHA class II or greater), unstable angina pectoris or
cardiac arrhythmia requiring maintenance medication

- Pregnant women are excluded from this study because ZD1839 is a signal transduction
inhibitor agent with the potential for teratogenic or abortifacient effects; there is
an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with ZD1839, breastfeeding should be discontinued if the
mother is treated with ZD1839

- Patients with known immune deficiency are at an increased risk when treated with
marrow-suppressive therapy, HIV-positive patients receiving combination
anti-retroviral therapy are excluded due to the possible pharmacokinetic interactions
with ZD1839; appropriate studies will be undertaken in patients receiving combination
anti-retroviral therapy when indicated

- CYP3A4 inducing agents; patients receiving the following CYP3A4 inducing agents will
be excluded; these include: carbamazepine, ethosuximide, griseofulvin, modafinil,
nafcillin, oxcarbazepine, Phenobarbital, phenylbutazone, phenytoin, rifampin,
rifabutin, St. John's Wort, and sulfinpyrazone

- Patients with distant metastatic disease as determined by diagnostic imaging (i.e.,
chest x-rays) and/or hematologic assessments (i.e., liver enzymes)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Early progression rate

Outcome Time Frame:

Up to 2 courses of induction therapy

Safety Issue:


Principal Investigator

Randal Weber

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2005

Completion Date:

Related Keywords:

  • Recurrent Skin Cancer
  • Squamous Cell Carcinoma of the Skin
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Squamous Cell
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous



M D Anderson Cancer Center Houston, Texas  77030