Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, sorafenib
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC Patients must have measurable or nonmeasurable disease Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease) Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50 mL/min More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other investigational drug use Recovered from all prior therapy Fertile patients must use effective contraception Age >= 18 ECOG performance status of 0-1 Exclusion Criteria: Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable and off therapy for at least 2 months Active second malignancy Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms of coronary heart disease Prior radiotherapy to the only site of measurable or evaluable disease unless there is evidence of disease progression in that site Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor) Concurrent medications known to be metabolized by the liver with a narrow therapeutic index, including the following: Ketoconazole Itraconazole Quinidine Digoxin Cyclosporine Ritonavir Grapefruit products Carbamazepine Phenytoin Phenobarbital Pregnant or nursing Clinically serious active infection Medical conditions, substance abuse or psychological/social situation that would preclude study participation
Sites / Locations
- Stanford Comprehensive Cancer Center - Stanford
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- Front Range Cancer Specialists
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Baptist Cancer Institute - Jacksonville
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Alexian Brothers Radiation Oncology
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Mason District Hospital
- Hinsdale Hematology Oncology Associates
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- Swedish-American Regional Cancer Center
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Clarian Arnett Cancer Care
- Saint Anthony Memorial Health Centers
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- Cedar Rapids Oncology Associates
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Morton Hospital & Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Foote Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - East Orange
- Somerset Medical Center
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Aultman Cancer Center at Aultman Hospital
- Christ Hospital Cancer Center
- Case Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- St. Rita's Medical Center
- St. Luke's Cancer Network at St. Luke's Hospital
- Bryn Mawr Hospital
- Geisinger Medical Center
- Easton Regional Cancer Center at Easton Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Central Pennsylvania Hematology and Medical Oncology Associates, PC
- Lewistown Hospital
- Cancer Center of Paoli Memorial Hospital
- Joan Karnell Cancer Center at Pennsylvania Hospital
- Geisinger Medical Group - Scenery Park
- Mount Nittany Medical Center
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
- Vanderbilt-Ingram Cancer Center
- UT Southwestern University Hospital - Zale Lipshy
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Fox Valley Hematology and Oncology - East Grant Street
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Dean Medical Center - Madison
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Other
Induction then Sorafenib
Induction then Placebo then Sorafenib
Induction, not randomized
Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression. Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.
Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression. Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm.
Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Post-induction: Patients with responding disease or disease progression were not randomized in Step 2. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression, while patients with disease progression were removed from the study.