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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00029003
First received: January 4, 2002
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Bronchoalveolar Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: gefitinib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Chronic Oral ZD1839 (Iressa®) (NSC-715055) in Both Previously-Untreated and Previously-Treated Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change in EGFR and EGFR variant III overexpression and their relationship with survival [ Time Frame: From baseline to up to 1 year ] [ Designated as safety issue: No ]
  • Response via CAIA versus response by RECIST [ Time Frame: At 16 weeks ] [ Designated as safety issue: No ]
  • Toxicity as assessed by CTCAE version 3.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: December 2001
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (gefitinib)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: gefitinib
Given orally
Other Names:
  • Iressa
  • ZD 1839
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the one-years survival rate in both previously-untreated and previously-treated patients with advanced bronchioalveolar carcinoma receiving chronic oral ZD1839.

II. To assess the progression-free survival and overall survival in these groups of patients.

III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.

IV. To evaluate the response rate using both the standard RECIST criteria and by computer-assisted image analysis in patients with measurable disease.

V. To measure EGFR and EGFR variant III overexpression in tumor tissue samples and explore their relationship with aforementioned clinical outcomes.

VI. To measure EGFR expression and activation status in slides of buccal brushings submitted on S9925 before and after initiation of treatment with ZD1839 and explore their association with response and survival.

OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchioalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)

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

Patients are followed every 6 months for 2 years and then annually thereafter.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patient with known brain metastases are ineligible for this clinical trial; if there are any abnormal findings on neurological examination suspicious for brain metastases, a CT or MRI should be performed within 42 days prior to registration
  • NOTE: a baseline slit lamp examination is NOT required; however, patients with eye symptoms (eye pain, tearing, redness, vision problems) should be evaluated by an ophthalmologist/optometrist prior to registration and the results documented on the S0126 Toxicity and Dosage Form
  • Patient must not have corneal inflammation or infection
  • Patients requiring agents that induce CYP3A4 are excluded from the study, due to the ability of these agents to significantly reduce plasma concentrations of ZD1839 potentially below the range likely to be biologically active if taken concurrently with ZD1839 at the dose employed in the study; at the present time, agents known to induce CYP3A4 include the antibiotics nafcillin and rifampin, the anticonvulsants carbamazepine, phenobarbital, and phenytoin, as well as St. John's wort
  • Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
  • No other prior malignancy is allowed except to the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
  • Pregnant or nursing women are not eligible to participate in this trial; women/men of reproductive potential must have agreed to use an effective contraceptive method
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029003

Locations
United States, Texas
Southwest Oncology Group
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: Howard West Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00029003     History of Changes
Other Study ID Numbers: NCI-2012-03073, S0126, U10CA032102, CDR0000069157
Study First Received: January 4, 2002
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma, Bronchiolo-Alveolar
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014