Spots Global Cancer Trial Database for Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
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Trial Identification
Brief Title: Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Official Title: A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer
Study ID: NCT00553462
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed Description: OBJECTIVES: Primary * To determine the activity of induction chemotherapy comprising carboplatin and paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage IIIA or IIIB non-small cell lung cancer. Secondary * To determine the response rate and progression-free survival of these patients. OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
East Bay Radiation Oncology Center, Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley, Castro Valley, California, United States
Valley Medical Oncology, Fremont, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
Camino Medical Group - Treatment Center, Mountain View, California, United States
El Camino Hospital Cancer Center, Mountain View, California, United States
Highland General Hospital, Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
Bay Area Breast Surgeons, Incorporated, Oakland, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Larry G Strieff MD Medical Corporation, Oakland, California, United States
Tom K Lee, Incorporated, Oakland, California, United States
Palo Alto Medical Foundation, Palo Alto, California, United States
Doctors Medical Center - San Pablo Campus, San Pablo, California, United States
Poudre Valley Radiation Oncology, Fort Collins, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States
Menorah Medical Center, Overland Park, Kansas, United States
Saint Luke's Hospital - South, Overland Park, Kansas, United States
CCOP - Kansas City, Prairie Village, Kansas, United States
Harold Alfond Center for Cancer Care, Augusta, Maine, United States
CancerCare of Maine at Eastern Maine Medical Center, Bangor, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
National Naval Medical Center, Bethesda, Maryland, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Boston University Cancer Research Center, Boston, Massachusetts, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City, Missouri, United States
St. Joseph Medical Center, Kansas City, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
Parvin Radiation Oncology, Kansas City, Missouri, United States
Heartland Hematology Oncology Associates, Incorporated, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States
Liberty Hospital, Liberty, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Joseph Oncology, Incorporated, Saint Joseph, Missouri, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Lakes Region General Hospital, Laconia, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital, Manchester, New Hampshire, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Southeastern Regional Medical Center, Lumberton, North Carolina, United States
Granville Medical Center, Oxford, North Carolina, United States
Rex Cancer Center at Rex Hospital, Raleigh, North Carolina, United States
Duke Health Raleigh Hospital, Raleigh, North Carolina, United States
Person Memorial Hospital, Roxboro, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Iredell Memorial Hospital, Statesville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
AnMed Cancer Center, Anderson, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States
Danville Regional Medical Center, Danville, Virginia, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton, Virginia, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, United States
Contact Details
Name: Rogerio Lilenbaum, MD
Affiliation: Cleveland Clinic Florida
Role: STUDY_CHAIR
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