Clinical trial NCT00616499: Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-02-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: Complete resection rate
measure: Overall survival rate
measure: Median disease-free survival
measure: Complete pathological response rate
measure: Toxicity
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center at Yonsei University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - University of Ulsan College of Medicine
Study officials:
affiliation: Yonsei University
name: Joo-Hang Kim, MD
role: STUDY_CHAIR
References: