MDACC Study Summary 2004-0204

Study Summary
No. 2004-0204:.......Skin......Randal Weber......Head/Neck Surgery

Study Summary Title



Study Summary Number:	2004-0204

Study Title:	A Phase II Study of ZD1839 and Radiation in Patients with Squamous Cell Carcinoma of the Skin

Physician

New Patient Referral



Name:	Randal Weber	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Head/Neck Surgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6520 Contact us about clinical trials

General Information



Disease Group:	Skin	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	4 return visits (every 2 wks. for 2 mos.) before surgery and/or radiation tx, based on randomization. If pt. joins 12 mo. Maintenance Ph., return visits scheduled every 4 wks, +/- 2 wks. Follow-up visits scheduled yearly as standard of care.

Treatment Agents:	ZD1839	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839) with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The safety of this treatment will also be studied.

Study Objectives / Outcomes

The primary objectives are to determine:

a. Early progression rate (progression during ZD1839 induction)

b. Feasibility of induction ZD1839 (for all patients) and concomitant

ZD1839 with radiotherapy (for unresectable patients).

c. Toxicities of induction ZD1839 (for all patients) and concomitant

ZD1839 with radiotherapy (for unresectable patients).

The secondary objectives are to describe:

a. Response: clinical responses to induction therapy.

b. Failures: frequency and timing of local and distant failures.

c. Biomarkers: biomarker levels in tumor and normal tissue.

The exploratory outcomes:

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

b. Feasibility of maintenance ZD1839.

c. Toxicities of maintenance ZD1839.

Study Status Information



Study Activation / Registration Date:	04/08/2005

IRB Review and Approval Date:	09/01/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	63 patients; 32 on one strata, 31 on the other strata

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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 diagnosis.

2) Patients may have previous surgical intervention with residual or recurrent disease.

3) Age >/= 18 years.

4) ECOG performance status </=2 (Karnofsky >/=60%).

5) Patients must have normal organ and marrow function as defined below: (1) leukocytes >/=3,000/mm*3; (2) absolute neutrophil count >/=1,500/mm*3; (3) platelets >/=100,000/mm*3; (4) total bilirubin within normal institutional limits; (5) AST (SGOT) and ALT (SGPT) </=2.5 X institutional upper limit of normal; (6) creatinine within normal institutional limits OR; (7) creatinine clearance >/=60 mL/min/1.73 m*2 for patients with creatinine levels above institutional normal.

6) 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.

7) 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.

8) 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 Participants."

Exclusion Criteria:

1) Patients who have previous radiotherapy to the proposed site of skin cancer.

2) Patients with active cancers other than skin.

3) 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.

4) Patients with a history of brain metastases.

5) History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839.

6) Age less than 18 years.

7) 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.

8) Breastfeeding Mothers treated with ZD1839 who do not agree to discontinue breastfeeding.

9) HIV-positive patients receiving combination anti-retroviral therapy.

10) Patients receiving the following CYP3A4 inducing agents (See Appendix G)

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

Links

Registration Number: NCT00126555
Study Information on Clinical Trials Registry (clinicaltrials.gov)