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.

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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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

188

Study ID:

NCT00126581

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 88 Locations for this study

See Locations Near You

East Bay Radiation Oncology Center
Castro Valley California, 94546, United States
Eden Hospital Medical Center
Castro Valley California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont California, 94538, United States
Saint Rose Hospital
Hayward California, 94545, United States
Contra Costa Regional Medical Center
Martinez California, 94553, United States
El Camino Hospital
Mountain View California, 94040, United States
Highland General Hospital
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Bay Area Tumor Institute
Oakland California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland California, 94609, United States
Tom K Lee Inc
Oakland California, 94609, United States
Valley Care Health System - Pleasanton
Pleasanton California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton California, 94588, United States
University of California San Diego
San Diego California, 92103, United States
Kaiser Permanente-San Diego Mission
San Diego California, 92108, United States
Veterans Administration-San Diego Medical Center
San Diego California, 92161, United States
UCSF Medical Center-Mount Zion
San Francisco California, 94115, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo California, 94806, United States
Middlesex Hospital
Middletown Connecticut, 06457, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Jupiter Medical Center
Jupiter Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
AMITA Health Adventist Medical Center
La Grange Illinois, 60525, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Community Howard Regional Health
Kokomo Indiana, 46904, United States
IU Health La Porte Hospital
La Porte Indiana, 46350, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka Indiana, 46545, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend Indiana, 46628, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore Maryland, 21237, United States
Union Hospital of Cecil County
Elkton Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Mass General/North Shore Cancer Center
Danvers Massachusetts, 01923, United States
Cape Cod Hospital
Hyannis Massachusetts, 02601, United States
Lowell General Hospital
Lowell Massachusetts, 01854, United States
South Shore Hospital
South Weymouth Massachusetts, 02190, United States
Lakeland Medical Center Saint Joseph
Saint Joseph Michigan, 49085, United States
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Missouri Cancer Associates
Columbia Missouri, 65201, United States
Veterans Administration
Columbia Missouri, 65201, United States
University of Missouri - Ellis Fischel
Columbia Missouri, 65212, United States
Capital Region Medical Center
Jefferson City Missouri, 65101, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Center for Cancer Care and Research
Saint Louis Missouri, 63141, United States
CHI Health Saint Francis
Grand Island Nebraska, 68803, United States
Great Plains Health Callahan Cancer Center
North Platte Nebraska, 69101, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Saint Joseph Hospital
Nashua New Hampshire, 03060, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse New York, 13057, United States
Northwell Health NCORP
Lake Success New York, 11042, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Ralph Lauren Center for Cancer Care and Prevention
New York New York, 10035, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Saint Joseph's Hospital Health Center
Syracuse New York, 13203, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wayne Memorial Hospital
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville North Carolina, 28791, United States
Vidant Oncology-Kinston
Kinston North Carolina, 28501, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Cancer Care Associates
Oklahoma City Oklahoma, 73120, United States
Memorial Hospital of Rhode Island
Pawtucket Rhode Island, 02860, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Miriam Hospital
Providence Rhode Island, 02906, United States
Roper Hospital
Charleston South Carolina, 29401, United States
McLeod Regional Medical Center
Florence South Carolina, 29506, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville South Carolina, 29615, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington Vermont, 05405, United States
Rappahannock General Hospital
Kilmarnock Virginia, 22482, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

188

Study ID:

NCT00126581

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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