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

NCT00588445 | Completed Phase 2 Results

• 2 other identifiers: 04-071CA113653
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Non-small Cell Lung Cancer; Bronchioloalveolar Cancer

Keywords

Lung Cancer; Non-small cell lung cancer; Gefitnib; Cancer; NSCLC; bronchioloalveolar cancer; smoker

Outcome Measures

Primary Outcomes (1)

• The Radiographic Response to Gefitinib

  Radiographic response is defined as a minor response ( \> 25% decrease in the sum of the products of measured lesions)

  21 days

Secondary Outcomes (1)

• Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Gefitinib

Interventions

Gefitinib DRUG

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.

Treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (2)

• Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

  PMID: 32198149 DERIVED

• 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.

  PMID: 20534736 DERIVED

Related Links

• Memorial Sloan-Kettering web site

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Charles Rudin
• Organization: Memorial Sloan Kettering Cancer Center

rudinc@mskcc.org

646-888-4527

Study Officials

• Naiyer Rizvi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 8, 2008
• Study Start: June 1, 2004
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 22, 2016
• Results First Posted: January 22, 2016

Record last verified: 2015-12

Locations

US (1)