Know Cancer

forgot password

A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens


- To determine the percent of patients maintaining stable disease or objective response
two months after randomization with continued sorafenib treatment, compared to patients
switched to placebo.

- To determine progression-free survival, overall survival, and response rate.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to number of prior chemotherapy regimens (2 vs more than 2) and prior epidermal
growth factor receptor inhibitor treatment (yes vs no).

- Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment
continues for 2 courses 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 are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral sorafenib twice daily for up to 1 year in the absence
of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral placebo twice daily for up to 1 year in the absence
of disease progression or unacceptable toxicity. Patients who develop disease
progression within 1 year after randomization cross over to arm I.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 311 patients will be accrued for this study within
approximately 3 years.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Patients Maintaining Stable Disease or Objective Response 2 Months After Randomization

Outcome Description:

Per RECIST Criteria (V1.0): Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions Progressive Disease (PD): >=20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of longest diameter recorded since randomization, or the appearance of new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Outcome Time Frame:

Two months after randomization

Safety Issue:


Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

March 2011

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • sorafenib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
North Suburban Medical Center Thornton, Colorado  80229
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Genesys Hurley Cancer Institute Flint, Michigan  48503
Foote Hospital Jackson, Michigan  49201
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
St. Rita's Medical Center Lima, Ohio  45801
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Dean Medical Center - Madison Madison, Wisconsin  53717
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Somerset Medical Center Somerville, New Jersey  08876
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Southwest Medical Center Liberal, Kansas  67901
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
UT Southwestern University Hospital - Zale Lipshy Dallas, Texas  75235
Front Range Cancer Specialists Fort Collins, Colorado  80528
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia, Pennsylvania  19107
Fox Valley Hematology and Oncology - East Grant Street Appleton, Wisconsin  54911-3496
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey, Illinois  60426
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Knoxville, Tennessee  37901
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
Morton Hospital & Medical Center Taunton, Massachusetts  02780
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Christ Hospital Cancer Center Cincinnati, Ohio  45219
St. Luke's Cancer Network at St. Luke's Hospital Bethlehem, Pennsylvania  18015
Easton Regional Cancer Center at Easton Hospital Easton, Pennsylvania  18042
Central Pennsylvania Hematology and Medical Oncology Associates, PC Lemoyne, Pennsylvania  17043
Stanford Comprehensive Cancer Center - Stanford Stanford, California  94305
Galesburg Clinic, PC Galesburg, Illinois  61401
Alexian Brothers Radiation Oncology Elk Grove Village, Illinois  60007
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Clarian Arnett Cancer Care Lafayette, Indiana  47904