Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

July 14, 2004

Primary Completion Date

January 31, 2012

Study Completion Date

August 31, 2012

Conditions
Extensive Stage Small Cell Lung Cancer
Interventions
BIOLOGICAL

G-CSF

G-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery \> 10,000 dL.

DRUG

Cisplatin

Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.

DRUG

Etoposide

Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.

DRUG

Irinotecan

50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).

DRUG

Topotecan

Topotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).

Trial Locations (79)

10466

Our Lady of Mercy Medical Center Comprehensive Cancer Center, The Bronx

17043

Central Pennsylvania Hematology and Medical Oncology Associates, PC, Lemoyne

18301

Dale and Frances Hughes Cancer Center at Pocono Medical Center, East Stroudsburg

18501

Mercy Hospital Cancer Center - Scranton, Scranton

18510

Hematology and Oncology Associates of Northeastern Pennsylvania, Scranton

19010

Bryn Mawr Hospital, Bryn Mawr

19013

Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center, Upland

19096

CCOP - MainLine Health, Wynnewood

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19380

Chester County Hospital, West Chester

19713

CCOP - Christiana Care Health Services, Newark

19958

Tunnell Cancer Center at Beebe Medical Center, Lewes

21701

Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick

21921

Union Hospital Cancer Program at Union Hospital, Elkton

31208

Medical Center of Central Georgia, Macon

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

45801

St. Rita's Medical Center, Lima

46350

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte

46360

Saint Anthony Memorial Health Centers, Michigan City

46515

Elkhart General Hospital, Elkhart

46601

CCOP - Northern Indiana CR Consortium, South Bend

Memorial Hospital of South Bend, South Bend

46617

Saint Joseph Regional Medical Center, South Bend

46904

Howard Community Hospital, Kokomo

47904

Clarian Arnett Cancer Care, Lafayette

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

49085

Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph

51101

Siouxland Hematology-Oncology Associates, LLP, Sioux City

51104

Mercy Medical Center - Sioux City, Sioux City

St. Luke's Regional Medical Center, Sioux City

52722

Bettendorf

54449

Marshfield Clinic - Marshfield Center, Marshfield

54476

Marshfield Clinic - Weston Center, Weston

54601

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse

54701

Regional Cancer Center at Sacred Heart Hospital, Eau Claire

54868

Marshfield Clinic - Indianhead Center, Rice Lake

57105

Avera Cancer Institute, Sioux Falls

Medical X-Ray Center, PC, Sioux Falls

60435

Joliet Oncology-Hematology Associates, Limited - West, Joliet

60461

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields

60504

Rush-Copley Cancer Care Center, Aurora

61265

Hematology & Oncology Care, Moline

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline

61801

Carle Cancer Center at Carle Foundation Hospital, Urbana

CCOP - Carle Cancer Center, Urbana

66720

Cancer Center of Kansas, PA - Chanute, Chanute

67042

Cancer Center of Kansas, PA - El Dorado, El Dorado

Cancer Center of Kansas, PA - Salina, Salina

67068

Cancer Center of Kansas, PA - Kingman, Kingman

67114

Cancer Center of Kansas, PA - Newton, Newton

67124

Cancer Center of Kansas, PA - Pratt, Pratt

67152

Cancer Center of Kansas, PA - Wellington, Wellington

67156

Cancer Center of Kansas, PA - Winfield, Winfield

67203

Associates in Womens Health, PA - North Review, Wichita

67208

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita

67214

Cancer Center of Kansas, PA - Wichita, Wichita

CCOP - Wichita, Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita

67357

Cancer Center of Kansas, PA - Parsons, Parsons

67801

Cancer Center of Kansas, PA - Dodge City, Dodge City

67901

Southwest Medical Center, Liberal

61104-2315

Swedish-American Regional Cancer Center, Rockford

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

49007-3731

West Michigan Cancer Center, Kalamazoo

08822

Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington

07601

CCOP - Northern New Jersey, Hackensack

08690

Cancer Institute of New Jersey at Hamilton, Hamilton

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

08903

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick

08043

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township

Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees Township

44309-2090

Summa Center for Cancer Care at Akron City Hospital, Akron

44106-5065

Case Comprehensive Cancer Center, Cleveland

19301-1792

Cancer Center of Paoli Memorial Hospital, Paoli

19107-5541

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

19612-6052

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading

57117-5039

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Eastern Cooperative Oncology Group

NETWORK

NCT00057837 - Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter