Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00411047 | Completed Phase 2 DMC

• 2 other identifiers: 04-291IRUSIRES0483
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with previously untreated stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate

Secondary Outcomes (5)

• Response duration, progression-free survival, and overall survival

• Safety

• Ability of various somatic activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene to predict response and toxicity

• Molecular profile

• Significance of germline polymorphisms of the EGFR gene, somatic amplification of the EGFR gene, and other molecular factors for their association with clinical outcome parameters

Interventions

gefitinib DRUG

oral drug taken daily around the same time

Also known as: IRESSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed non-small cell lung cancer (NSCLC) * No squamous cell histology * Stage IIIB (with pleural effusion) or stage IV disease * Must meet ≥ 1 of the following criteria: * Female * Adenocarcinoma tumor histology * No history of smoking, defined as smoking \< 100 cigarettes (5 standard packs of cigarettes) in a lifetime, \< 20 oz of pipe tobacco in a lifetime, OR \< 100 cigars in a lifetime * Asian/Pacific Rim ethnicity, defined as Japanese, Chinese, Korean, or other Asian/Pacific Rim ethnicity * Must have activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene * Measurable disease * No symptomatic or newly diagnosed CNS metastases that have not been definitively treated with radiotherapy and/or surgery * History of CNS metastases or cord compression allowed if definitively treated and clinically stable PATIENT CHARACTERISTICS: * See Disease Characteristics * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Absolute neutrophil count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.25 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN (5 times ULN if liver has tumor involvement) * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known severe hypersensitivity to gefitinib or any other component of gefitinib tablets * No evidence of clinically active interstitial lung disease * Patients with chronic, stable radiographic changes who are asymptomatic are eligible * No other concurrent malignancy or malignancy diagnosed within the past 5 years except for basal cell carcinoma of the skin or cervical cancer in situ * No concurrent severe or uncontrolled systemic disorder * No evidence of any other significant clinical disorder or laboratory finding that, in the opinion of the investigator, would preclude study participation * Able to tolerate protocol treatment, in the opinion of the investigator PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior systemic chemotherapy, biological therapy, immunotherapy, or hormonal therapy for NSCLC, including adjuvant and neoadjuvant treatment * No prior radiotherapy to the target lesion * Prior radiotherapy to bony disease or CNS disease allowed * At least 2 weeks since prior radiotherapy and recovered * More than 30 days since prior non-FDA approved or investigational agents * No prior EGFR antagonists * At least 2 weeks since prior and no concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort) * No concurrent chemotherapy, immunotherapy, hormonal therapy, nonpalliative radiotherapy, surgery for cancer, or other experimental medications * No other concurrent specific antitumor therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lecia V Sequist, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: September 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: December 1, 2012
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

US (1)