Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene
|ClinicalTrials.gov Identifier: NCT00588445|
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : January 22, 2016
Last Update Posted : January 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Non-small Cell Lung Cancer Bronchioloalveolar Cancer||Drug: Gefitinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2004|
|Primary Completion Date :||September 2010|
|Study Completion Date :||September 2010|
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.
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588445
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Naiyer Rizvi, MD||Memorial Sloan Kettering Cancer Center|