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Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588445
First Posted: January 8, 2008
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
December 26, 2007
January 8, 2008
December 17, 2015
January 22, 2016
January 22, 2016
June 2004
September 2010   (Final data collection date for primary outcome measure)
The Radiographic Response to Gefitinib [ Time Frame: 21 days ]
Radiographic response is defined as a minor response ( > 25% decrease in the sum of the products of measured lesions)
To correlate the radiographic response to gefitinib with the presence of mutations in the protein-tyrosine kinase domain of the EGF receptor gene in tumor specimens obtained before treatment with gefitinib. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00588445 on ClinicalTrials.gov Archive Site
Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data [ Time Frame: 2 years ]
Each patient provides two binary variables: presence/absence of mutation and responder/non responder. The association between the two will be tested using the Fisher's exact test for the resulting 2x2 table.Changes in expression levels within a patient will be assessed using a paired t-test. Similarly differences in expression levels between responders and non-responders will be assessed using a two-sample t-test. Appropriate adjustment will be made for the multiple comparisons problem that arises because there are over 21,000 probe sets on the U133A array.
Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data [ Time Frame: 2 years ]
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Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene
Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene in Patients With NSCLC

The purpose of this research study is to:

  • see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
  • see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
  • see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
  • see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
  • see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.

Patients must have 1 or more of the following features: never smoker or smoking history of < 15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery (depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before their operation. For patients that demonstrate a radiographic response to gefitinib preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years post-surgery. Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lung Cancer
  • Non-small Cell Lung Cancer
  • Bronchioloalveolar Cancer
Drug: Gefitinib

Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.

Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.

Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy.

Experimental: Treatment
Intervention: Drug: Gefitinib
Zhao B, Oxnard GR, Moskowitz CS, Kris MG, Pao W, Guo P, Rusch VM, Ladanyi M, Rizvi NA, Schwartz LH. A pilot study of volume measurement as a method of tumor response evaluation to aid biomarker development. Clin Cancer Res. 2010 Sep 15;16(18):4647-53. doi: 10.1158/1078-0432.CCR-10-0125. Epub 2010 Jun 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologic confirmation of malignancy at Memorial Sloan-Kettering
  • Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features)
  • Patients must have been determined to be operable and resectable by the treating thoracic surgeon.
  • Age >18 years.
  • Measurable indicator lesions
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.
  • Patients may not be receiving any other investigational agents.
  • Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00588445
04-071
CA113653
Not Provided
Not Provided
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: Naiyer Rizvi, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP