SWOG clinical trial number
S0126
Phase II Trial of Chronic Oral ZD1839 (Iressa) in Both Previously-Untreated and Previously-Treated Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Abbreviated Title
ZD1839/BAC/Previously-Untreated & Previously-Treated; Selected IIIB & IV
Pts. must have biopsy-proven, incompletely resected or unresectable BAC, Stage IIIB (w/pleural effusion) or Stage IV with pathology tissue available for central review and staining for EGFR and other molecular variables (bronchial brushings or washings alone not acceptable); pts. must have evidence of dz by CT; pts. must have prior systemic therapy, if done, (biologics, chemo or RT) completed >= 4 weeks; pts. must have recovered from any surgery; pts. dz must be present outside of prior RT port; pts. abnormal Alk Phos followed to document possible liver or bone mets; bili <= 1.5 X IULN, Alk Phos and SGOT or SGPT <= 2.5 X IULN; PS 0-2; ANC >= 1,500, WBC <= 3,000 and PLTS >= 100,000; pts. must not have prior cancer except for adequately treated basal or SCC of skin, in situ cervical ca, adequately treated Stage I or II ca from which the patient is currently in complete remission or other ca for which pt. has been dz-free for >= 5 yrs; pts. must not be pregnant or nursing or of reproductive potential and not agreed to use effective contraceptive method; pts. w/brain mets are ineligible - any suspicious neuro findings need to be followed by CT/MRI; no prior treatment with EGFR-targeting therapies or other treatment directed at their BAC; pts. must not have uncontrolled intercurrent illness, GI tract dz resulting in the inability to take oral meds or requirement for IV alimentation, prior surgery affecting absorption or corneal inflammation or infection; pts. must not be taking agents that induce CYP3A4. Pts. must be offered participation in S9925 (Lung Cancer Specimen Repository)
2008
Long-term survival with gelfitinib (ZD1839) therapy for advanced bronchioalveolar lung cancer (BAC). Southwest Oncology Group Study S0126
HL West;K Chansky;WA Franklin;D Hirsch;JJ Crowley;DH Lau;DR Gandara Journal of Clinical Oncology 26(15S):435s, #8047
2007
Combination of EGFR gene copy number and protein expression predicts outcome for advanced non-small cell lung cancer patients treated with gefitinib [PMID17317677]
FR Hirsch;M Varella-Garcia;F Cappuzzo;J McCoy;L Bemis;AC Xavier;R Dziadziuszko;P Gumerlock;K Chansky;H West;AF Gazdar;L Crino;D Gandara;W Franklin;PA Bunn Annals of Oncology 18(4):752-760
2006
Gefitinib therapy in advanced bronchioloalveolar carcinoma: Southwest Oncology Group study S0126
HL West;WA Franklin;J McCoy;P Gumerlock;R Vance;DHM Lau;K Chansky;JJ Crowley;DR Gandara Journal of Clinical Oncology 24(12):1807-1813
2005
Increased EGFR gene copy number detected by fish is associated with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma (BAC) (S0126)
FR Hirsch;DR Gandara;J McCoy;J Crowley;HJ West;PH Gumerlock;PA Bunn;WA Franklin;M Varella-Garcia Proc of the ASCO, JCO 23(16S):628s (#7030)
Increased epidermal growth factor receptor gene copy number detected by fluorescence in situ hybridization associates with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma subtypes: a Southwest Oncology Group study
FR Hirsh;M Varella-Garcia;J McCoy;H West;AC Xavier;P Gumerlock;PA Bunn Jr;WA Franklin;J Crowley;DR Gandara Journal of Clinical Oncology 23(28):6838-6845
Mutational analysis of K-RAS and EGFR implicates K-RAS as a resistance marker in the Southwest Oncology Group (SWOG) trial S0126 of bronchioalveolar carcinoma (BAC) patients (pts) treated with gefitinib
PH Gumerlock;WS Holland;H Chen;WA Franklin;FR Hirsch;PC Mack;AM Davies;J McCoy;HJ West;DR Gandara Proc of the ASCO, JCO 23(16S):623s (#7008)
2004
Gefitinib (ZD1839) therapy for advanced bronchioloalveolar lung cancer (BAC): Southwest Oncology Group (SWOG) study S0126.
H West;WA Franklin;PH Gumerlock;RB Vance;DHM Lau;J McCoy;J Crowley;DR Gandara Proc of the American Society of Clinical Oncology 23:618 (#7014)
Bronchioloalveolar carcinoma: a model for investigating the biology of epidermal growth factor receptor inhibition
DR Gandara;H West;K Chansky;AM Davies;DHM Lau;J Crowley;PH Gumerlock;FR Hirsh;WA Franklin Clinical Cancer Research 10 (Suppl):4205s-4209s
