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

PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Lung CancerNon-small Cell Lung CancerBronchioloalveolar Cancer
Interventions
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."

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00588445 - Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene | Biotech Hunter | Biotech Hunter