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

NCT00029003 | Completed Phase 2

• 4 other identifiers: NCI-2012-03073S0126U10CA032102CDR0000069157
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer

Conditions

Bronchoalveolar Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  Up to 1 year

Secondary Outcomes (4)

• Progression-free survival

  From the date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 2 years

• Change in EGFR and EGFR variant III overexpression and their relationship with survival

  From baseline to up to 1 year

• Response via CAIA versus response by RECIST

  At 16 weeks

• Toxicity as assessed by CTCAE version 3.0

  Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (gefitinib)

EXPERIMENTAL

Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: gefitinib; Other: laboratory biomarker analysis

Interventions

gefitinib DRUG

Given orally

Also known as: Iressa, ZD 1839

Treatment (gefitinib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (gefitinib)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a biopsy-proven, incompletely resected or unresectable bronchioloalveolar carcinoma, with pathology tissue available for central review and staining for EGFR and other molecular variables; fine needle aspirates, bronchial brushings or washings are not permitted for diagnosis; patients must have either selected stage IIIB due to cytology-confirmed malignant pleural effusion, or stage IV disease; tumors may be multi-focal or diffuse
• Patients must have evidence of disease by CT scan of the chest; the pre-study CT scan of the chest must include the liver and adrenal glands or be accompanied by an abdominal CT scan in which they are visualized; all x-rays/scans to assess measurable disease must have performed within 28 days prior to registration; all other required tests to assess non-measurable disease must have been performed within 42 days prior to registration
• The institution must plan to submit all pathology materials (i.e., H\&E stained slide from each block, plus 10 unstained slide from one block) within 30 days after registration
• All patients must have a Zubrod performance status of 0-2
• Patients must not have received prior treatment with biologic therapies that target EGFR; patients may not be currently receiving or planning to receive any other treatment directed at the BAC
• Prior biologic therapy, chemotherapy and radiotherapy are allowed, provided that at least four weeks have elapsed since last treatment with these modalities and the patient's disease has been assessed since completing previous treatment; disease must be present outside of areas of previous radiation therapy
• Prior surgery is allowed, provided that the patient has had sufficient recovery time from surgery, as determined by the enrolling physician
• Patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation; patients must not have had prior surgical procedures affecting absorption
• Serum bilirubin =\< 1.5 x the institutional upper limit of normal
• SGOT or SGPT =\< 2.5 x the institutional upper limit of normal (IULN) (if liver metastases are present; SGOT/SGPT =\< 5 IULN allowed)
• Alkaline phosphatase =\< 2.5 x IULN (if bone metastases are present, alkaline phosphatase =\< 5 x IULN is allowed); abnormalities in alkaline phosphatase levels should be appropriately followed to document the possibility of bone or hepatic metastases
• ANC \>= 1,500/uL
• WBC \>= 3,000/uL
• Platelet count \>= 100,000/uL
• Institution must have receive IRB approval for S9925; patients must be offered participating in S9925 (the Lung Cancer Specimen Repository); optional submissions of buccal brushings for EGFR determination will be done via the Lung Cancer Specimen Repository; patients must be registered separately to S9925 to receive credit for buccal brushing submission

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

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

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Howard West

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: December 1, 2001
• Primary Completion: December 1, 2004
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)