Status:
COMPLETED
Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lung Adenocarcinoma
Lung Adenosquamous Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hy...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the distribution of progression-free survival (PFS) in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologic documentation of primary lung adenocarcinoma including any variant thereof such as pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma; patients with non-small cell lung cancer (NSCLC) not otherwise specified (NOS) are not eligible
- Pathology block or unstained slides from initial or subsequent diagnosis must be available for sequencing of EGFR, K-ras, Erb-2 and B-raf; patients need to have had at least a core biopsy; patients whose diagnosis was made through a fine needle aspirate will not have sufficient material for mutational analysis and are not eligible
- Select stage IIIB with cytologically documented malignant pleural or pericardial effusion OR stage IV disease
- Patients must be chemotherapy naïve; they may not have received neo-adjuvant or adjuvant chemotherapy
- No prior exposure to OSI-774 (erlotinib) or other treatments targeting the human epidermal growth factor receptor (HER) family axis (e.g., trastuzumab, gefitinib, cetuximab, lapatinib, etc.)
- No uncontrolled central nervous system metastases (i.e., any known central nervous system \[CNS\] lesion which is radiographically unstable, symptomatic and/or requiring corticosteroids); patients must be \>= 3 weeks beyond completing cranial irradiation and off corticosteroid therapy
- \>= 3 weeks since prior radiation therapy
- \>= 3 weeks since prior major surgery
- No treatment with an investigational agent currently or within the last 28 days
- Non-smoker or former light smoker; non-smoker is defined as a person who smoked =\< 100 cigarettes in their lifetime while a former light smoker is a patient who smoked between \> 100 cigarettes AND =\< 10 pack years AND quit \>= 1 year ago; this must be documented on the On-study Form (C-1405)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Non-pregnant and non-nursing
- No dysphagia or active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption; no lack of integrity of the gastrointestinal tract (e.g., a significant surgical resection of the stomach or small bowel); patients unable to swallow intact tablets must be able to swallow tablets dissolved in water
- Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan; lesions that are considered non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Granulocyte \>= 1,500/mcl
- Platelet count \>= 100,000/mcl
- Hemoglobin \>= 9.0 g/dL
- Total bilirubin =\< upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x ULN
- Creatinine =\< 1.5 mg/dl
Exclusion
Key Trial Info
Start Date :
August 15 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2017
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00126581
Start Date
August 15 2005
End Date
November 28 2017
Last Update
August 7 2019
Active Locations (96)
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1
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
2
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
3
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
4
Bay Area Breast Surgeons Inc
Emeryville, California, United States, 94608