Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Locally advanced stage IIIA or IIIB disease that is considered unresectable No stage IV disease Requires radiotherapy Performance status (PS) - Eastern Cooperative Oncology Group (ECOG) 0-1 At least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) aspartate aminotransferase (AST) ≤ 3 times ULN Creatinine ≤ 1.5 times ULN No New York Heart Association class III or IV heart disease Forced expiratory volume (FEV) FEV_1 ≥ 1 L OR 35% of predicted Weight loss < 10% within the past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No peripheral neuropathy ≥ grade 2 No other severe underlying disease that would preclude study participation No uncontrolled infection No unhealed wound within the past 2 weeks No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) No prior systemic chemotherapy for NSCLC* No prior radiotherapy to the chest More than 2 weeks since prior major surgery Contraindications Any of the following: Pregnant wome Nursing women Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) as this regimen may be harmful to a developing fetus or nursing child NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Any of the following prior therapies: Prior radiation therapy to the chest Prior systemic chemotherapy for NSCLC (phase II portion) New York Heart Association classification III or IV (see Appendix II). Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study. uncontrolled infection. Major surgery or unhealed wound ≤ 2 weeks prior to registration. Prior history of malignancy ≤ 5 years, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer. Peripheral neuropathy ≥grade 2
Sites / Locations
- Mayo Clinic in Arizona
- Saint Francis Hospital and Medical Center
- Mayo Clinic in Florida
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Saint Joseph Medical Center
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Saint Anthony Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- Galesburg Cottage Hospital
- Illinois CancerCare Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Havana
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Joliet Oncology-Hematology Associates Limited
- Illinois CancerCare-Kewanee Clinic
- Kewanee Hospital
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Community Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Pekin Cancer Treatment Center
- Pekin Hospital
- Illinois CancerCare-Pekin
- Methodist Medical Center of Illinois
- Proctor Hospital
- OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Illinois CancerCare-Spring Valley
- Saint Margaret's Hospital
- Valley Cancer Center
- Carle Clinic-Urbana Main
- Carle Foundation - Carle Cancer Center
- Saint Anthony Memorial Health Center
- Saint Luke's Hospital
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Siouxland Regional Cancer Center
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Hospital District Sixth of Harper County
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wesley Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- Oakwood Hospital
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Allegiance Health
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Harris, John Gilbert MD (UIA Investigator)
- Brainerd Medical Center Inc
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Duluth Clinic CCOP
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Metro-Minnesota CCOP
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Adult and Pediatric Urology PLLP
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Woodwinds Health Campus
- Rutherford Hospital
- Bismarck Cancer Center
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Altru Cancer Center
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazelton
- Geisinger Medical Group
- Geisinger Wyoming Valley
- AnMed Health Hospital
- Spartanburg Regional Medical Center
- Upstate Carolina CCOP
Arms of the Study
Arm 1
Experimental
Treatment (bortezomib, paclitaxel, carboplatin)
PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy bortezomib: Given IV paclitaxel: Given IV carboplatin: Given IV