MDACC Study Summary 2004-0221

Study Summary
No. 2004-0221:.......Lung......Edward Kim......Thoracic and Head and Neck Med

Study Summary Title



Study Summary Number:	2004-0221

Study Title:	Neoadjuvant chemotherapy with Docetaxel, Cisplatin followed by Maintenance Therapy with the EGFR inhibitor Erlotinib (Tarceva) in Patients with Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection

Physician

New Patient Referral



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

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

Phone:	713-792-6363 Contact us about clinical trials

General Information



Disease Group:	Lung	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients return to MDACC every 3 wks for 3 courses of chemotherapy. After 3 courses of chemotherapy, pts will return to MDACC following surgery, 60 and 90 days after Day 1 of erlotinib, then every 90 days while taking erlotinib for follow-up tests.

Treatment Agents:	Cisplatin Docetaxel Erlotinib	Home Care:	None.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to learn if chemotherapy
(cisplatin, docetaxel) is safe to give to patients whose lung cancer will be
surgically removed, and to learn if maintenance therapy with the biologic agent
erlotinib, given after surgery, is safe. Another goal of this study is to look
at changes that occur in epidermal growth factor receptor (EGFR) and how these
changes are reflected in different cells in the body. The effect of this
treatment on the participant's quality of life and survival, as well as its
effect on different cells in the body, will also be studied.

Study Objectives / Outcomes

Primary objectives are:
1. To evaluate the safety/toxicity of neoadjuvant chemotherapy with cisplatin and docetaxel followed by maintenance therapy with the EGFR inhibitor erlotinib in patients with stage I-III non-small cell lung cancer (NSCLC) undergoing definitive treatment with surgery and/or radiation.
2. To estimate the agreement in baseline to post-treatment changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue.

Secondary objectives are:
1. To evaluate the disease free survival of this therapeutic combination.
2. To assess overall quality of life.
3. To evaluate predictive biomarkers in early-stage NSCLC.

Study Status Information



Study Activation / Registration Date:	10/05/2005

IRB Review and Approval Date:	06/16/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	50

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) Patients must have histologically or cytologically confirmed diagnosis of stage I, II or III non-small cell lung cancer. Tissue blocks or slides will be requested.

2) Patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation.

3) Patients must be able to tolerate systemic chemotherapy prior to surgical resection.

4) Age >=18 years

5) No acute intercurrent illness or infection.

6) ECOG performance status 0-1

7) Normal organ and marrow function defined as: a) leukocytes >=3,000/uL, ANC>=1,500/uL, platelets>=100,000/uL, hemoglobin>=8g/dL, creatinine w/in normal institutional limits OR b) creatinine clearance>=60 mL/min/1.73 m**2 for patients with creatinine levels above institutional normal, bilirubin w/in normal institutional limits, alk phos<=2.5xULN AND AST or ALT<=1.5xULN. If alk phos>2.5xULN but <=5xULN, pt is eligible if AST or ALT<=ULN. If AST or ALT>1.5xULN but <=5xULN, pt is eligible if alk phos is <=ULN.

8) Prior to study enrollment, all women of child-bearing potential must have a negative pregnancy test. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

9) Patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.

10) Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1) Patients who have had prior chemotherapy or radiotherapy for lung cancer.

2) Patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-EGFR drugs.

3) Patient has signs or symptoms of acute infection requiring systemic therapy.

4) Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.

5) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Functional Classification class II or worse), unstable angina pectoris, serious or clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

6) Patients refusing to sign the informed consent.

7) Patients with pre-existing peripheral neuropathy NCI CTC grade 2 or worse.

8) Patients must not be pregnant or breast-feeding and all (male and female) must use a contraceptive method deemed acceptable by the investigator while receiving active treatment in the study and for up to two months following completion of therapy.

9) Patients with a history of severe hypersensitivity reaction to Taxotere� and or polysorbate 80 must be excluded.

Links

Registration Number: NCT00254384
Study Information on Clinical Trials Registry (clinicaltrials.gov)