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

NCT ID: NCT00411047

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-12-31

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.

Detailed Description

OBJECTIVES:

Primary

• Determine the objective tumor response rate in patients with previously untreated stage IIIB or IV non-small cell lung cancer with somatic activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene treated with gefitinib.

Secondary

• Determine response duration, progression-free survival, and overall survival of patients treated with this drug.
• Determine the safety of this drug in these patients.
• Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict response in patients treated with this drug.
• Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict toxicity of this drug in these patients.
• Define a molecular profile in patients who initially respond to treatment with this drug but subsequently progress on therapy.
• Determine the 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 in these patients.

OUTLINE: This is an open-label study.

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

gefitinib

oral drug taken daily around the same time

Intervention Type: DRUG

Other Intervention Names

IRESSA

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lecia V. Sequist

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lecia V Sequist, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Related Links

http://cancer.gov/clinicaltrials

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

Other Identifiers

IRUSIRES0483

Identifier Type: OTHER

Identifier Source: secondary_id

04-291

Identifier Type: -

Identifier Source: org_study_id