Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00616499
• Other study ID #: CDR0000582623
• Secondary ID: YONSEI-4-2006-01
• Status: Recruiting
• Phase: Phase 2
• First received: February 14, 2008
• Last updated: February 6, 2009
• Start date: November 2006

Study information

• Verified date: September 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations.

Secondary

• To determine the complete resection rate in patients treated with this drug.

• To determine the overall survival rate in patients treated with this drug.

• To determine the disease-free survival rate in patients treated with this drug.

• To determine the pathologic complete response rate in patients treated with this drug.

• To determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients with resectable disease may undergo surgery. Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.

After completion of study therapy, patients are followed for 2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer

• pN2 disease proven by mediastinoscopy

• Meets any of the following criteria:

• Never smoked

• EGFR mutations (in exon 18, 19, or 21)*

• FISH positive for EGFR* NOTE: *Irrespective of smoking history

• Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST

• Feasible to undergo pneumonectomy or lobectomy

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-1

• FEV_1 = 2.0 L in preoperative pulmonary function test

• Hemoglobin = 9.0 g/dL

• WBC 4,000-12,000/µL

• ANC = 1,500/µL

• Platelet count = 100,000/mm³

• Total bilirubin = 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase = 3.0 times ULN

• AST and ALT = 3.0 times ULN

• Creatinine = 1.5 times ULN

• Negative pregnancy test

Exclusion criteria:

• Severe complications or infections

• Pregnant or breast-feeding women

• Clinically significant heart disease

• Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus

• Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy, chemotherapy, hormone therapy, or target therapy

• No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gefitinib

Procedure:
• neoadjuvant therapy

• therapeutic conventional surgery

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center - University of Ulsan College of Medicine	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei Cancer Center at Yonsei University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	Complete resection rate			No
Secondary	Overall survival rate			No
Secondary	Median disease-free survival			No
Secondary	Complete pathological response rate			No
Secondary	Toxicity			Yes