Ovarian Cancer Clinical Trial

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

Summary

RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib.

PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.

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Full Description

OBJECTIVES:

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

342

Study ID:

NCT00064350

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 123 Locations for this study

See Locations Near You

Stanford Comprehensive Cancer Center - Stanford
Stanford California, 94305, United States
Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
Front Range Cancer Specialists
Fort Collins Colorado, 80528, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction Colorado, 81502, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80502, United States
St. Mary - Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Baptist Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
St. Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Alexian Brothers Radiation Oncology
Elk Grove Village Illinois, 60007, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
Swedish-American Regional Cancer Center
Rockford Illinois, 61104, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Clarian Arnett Cancer Care
Lafayette Indiana, 47904, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Morton Hospital & Medical Center
Taunton Massachusetts, 02780, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Foote Hospital
Jackson Michigan, 49201, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park Minnesota, 55416, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
Somerset Medical Center
Somerville New Jersey, 08876, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
Aultman Cancer Center at Aultman Hospital
Canton Ohio, 44710, United States
Christ Hospital Cancer Center
Cincinnati Ohio, 45219, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Easton Regional Cancer Center at Easton Hospital
Easton Pennsylvania, 18042, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne Pennsylvania, 17043, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia Pennsylvania, 19107, United States
Geisinger Medical Group - Scenery Park
State College Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College Pennsylvania, 16803, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville Tennessee, 37901, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas Texas, 75235, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston West Virginia, 25304, United States
Fox Valley Hematology and Oncology - East Grant Street
Appleton Wisconsin, 54911, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
Dean Medical Center - Madison
Madison Wisconsin, 53717, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc Wisconsin, 54221, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

342

Study ID:

NCT00064350

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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