Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer
Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Lung
Eligibility Criteria
Inclusion Criteria: Histologically confirmed non-small cell lung cancer Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar) Large cell carcinoma (including giant and clear cell carcinomas) Stage IIIA (T1 or T2, N2) or IIIB disease not amenable to resection or surgery T3, N2 or T4, N0-N2 disease also allowed if based on the closeness to the carina, invasion of the mediastinum, or invasion of the chest wall T3, N0-N1 disease allowed provided the disease is not amenable for surgical resection No M1 disease No disease invasion of a vertebral body Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiotherapy boost field and there is no bone invasion Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiotherapy boost field Pleural effusion that is transudative, cytologically negative, and non-bloody allowed if the tumor can be encompassed in a reasonable field of radiotherapy No exudative, bloody, or cytologically malignant effusions Effusions present on CT scans but not on chest x-ray (CXR) and too small for thoracentesis are allowed Measurable or evaluable disease Pleural effusions are not considered measurable or evaluable Measurable disease is defined as any mass in 2 perpendicular diameters by CXR, CT scan, or MRI Evaluable disease includes lesions apparent on CXR or CT scan that are: Ill-defined masses associated with post-obstructive changes Mediastinal or hilar adenopathy measurable in only one dimension Performance status - ECOG 0-1 Performance status - Karnofsky 70-100% More than 6 months WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin normal AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase normal AST and ALT normal and alkaline phosphatase no greater than 2.5 times ULN Creatinine normal Creatinine clearance at least 50 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No history of cornea abnormalities (e.g., dry-eye syndrome, Sjögren's syndrome) No congenital abnormality (e.g., Fuch's dystrophy) No abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose) No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) No gastrointestinal tract disease resulting in the inability to take oral medications No required IV alimentation No peptic ulcer disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergy to compounds of similar chemical or biologic composition to erlotinib or other study agents No significant traumatic injury within the past 21 days No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other active malignancy within the past 6 months except non-melanoma skin cancer No concurrent colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) with radiotherapy No prior chemotherapy for lung cancer See Disease Characteristics No prior chest radiotherapy See Disease Characteristics At least 7 days since prior mediastinoscopy More than 3 weeks since prior formal exploratory thoracotomy More than 3 weeks since prior major surgery No prior surgical procedures affecting absorption No prior epidermal growth factor receptor-targeting therapies No other concurrent investigational or commercial agents or therapies directed at malignancy No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I (cisplatin, etoposide, erlotinib, and docetaxel)
Group II (paclitaxel, carboplatin, and erlotinib
Patients receive cisplatin IV over 2 hours on days 1, 8, 29, and 36; etoposide IV over 1 hour on days 1-5 and 29-33; and oral erlotinib once daily on days 1-49. Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1. Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50, 71, and 92. Some patients may also receive oral erlotinib once daily on days 50-112.
Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21. Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43, 50, 57, 64, 71, 78, and 85 and oral erlotinib once daily on days 43-91. Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43.