Lung Cancer Clinical Trial
Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
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 hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.
Full 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 treated with either OSI-774 (erlotinib) (erlotinib hydrochloride) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
SECONDARY OBJECTIVES:
I. To determine the radiographic response rate in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
II. To determine the frequency of epidermal growth factor receptor (EGFR) and V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations and anaplastic lymphoma kinase (ALK) translocations in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers.
III. To determine the response rate and time to progression in patients with and without EGFR mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
IV. To determine the response rate and time to progression in patients with and without K-ras mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
V. To determine the median and overall survival of patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
VI. To estimate the response rate, progression-free, and overall survival of patients with echinoderm microtubule associated protein like (EML)4-ALK translocation who received OSI-774 erlotinib alone (arm A) or in combination with carboplatin/paclitaxel (arm B).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive erlotinib hydrochloride as in Arm I. Patients also receive paclitaxel intravenously (IV) over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.
Eligibility Criteria
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
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There are 88 Locations for this study
Castro Valley California, 94546, United States
Castro Valley California, 94546, United States
Castro Valley California, 94546, United States
Emeryville California, 94608, United States
Fremont California, 94538, United States
Hayward California, 94545, United States
Martinez California, 94553, United States
Mountain View California, 94040, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Pleasanton California, 94588, United States
Pleasanton California, 94588, United States
San Diego California, 92103, United States
San Diego California, 92108, United States
San Diego California, 92161, United States
San Francisco California, 94115, United States
San Pablo California, 94806, United States
Middletown Connecticut, 06457, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20010, United States
Fort Lauderdale Florida, 33308, United States
Jupiter Florida, 33458, United States
Miami Beach Florida, 33140, United States
Savannah Georgia, 31404, United States
Chicago Illinois, 60637, United States
La Grange Illinois, 60525, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46628, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21237, United States
Elkton Maryland, 21921, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Danvers Massachusetts, 01923, United States
Hyannis Massachusetts, 02601, United States
Lowell Massachusetts, 01854, United States
South Weymouth Massachusetts, 02190, United States
Saint Joseph Michigan, 49085, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65212, United States
Jefferson City Missouri, 65101, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63141, United States
Grand Island Nebraska, 68803, United States
North Platte Nebraska, 69101, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89102, United States
Nashua New Hampshire, 03060, United States
Camden New Jersey, 08103, United States
New Brunswick New Jersey, 08903, United States
Buffalo New York, 14263, United States
East Syracuse New York, 13057, United States
Lake Success New York, 11042, United States
Manhasset New York, 11030, United States
New Hyde Park New York, 11040, United States
New York New York, 10035, United States
New York New York, 10065, United States
Syracuse New York, 13203, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
Kinston North Carolina, 28501, United States
Wilson North Carolina, 27893, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73120, United States
Pawtucket Rhode Island, 02860, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02906, United States
Charleston South Carolina, 29401, United States
Florence South Carolina, 29506, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05405, United States
Kilmarnock Virginia, 22482, United States
Richmond Virginia, 23298, United States
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