Back to results

S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

cisplatin

etoposide

irinotecan hydrochloride

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants) PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal Creatinine normal Creatinine clearance at least 50 mL/min Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative No concurrent AIDS-related illness PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for SCLC No filgrastim (G-CSF) within 24 hours of chemotherapy Chemotherapy No prior systemic chemotherapy for SCLC Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics At least 21 days since prior brain radiotherapy and recovered No other prior radiotherapy for SCLC Surgery See Disease Characteristics At least 21 days since prior thoracic or other major surgery and recovered Other No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)

Sites / Locations

Northeast Alabama Regional Medical Center
Huntsville Hospital
Mobile Infirmary Medical Center
East Alabama Medical Center
Alaska Regional Hospital Cancer Center
Mayo Clinic Scottsdale
Arizona Cancer Center at University of Arizona Health Sciences Center
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Providence Saint Joseph Medical Center - Burbank
Cancer Care Center at John Muir Health - Concord Campus
Washington Township Hospital
California Cancer Center - Woodward Park Office
USC/Norris Comprehensive Cancer Center and Hospital
Desert Regional Medical Center Comprehensive Cancer Center
Shasta Regional Medical Center
Sutter Cancer Center at Roseville Medical Center
Sutter Cancer Center
University of California Davis Cancer Center
CCOP - Santa Rosa Memorial Hospital
John Muir/Mt. Diablo Comprehensive Cancer Center
Memorial Hospital
Eastern Connecticut Hematology and Oncology Associates
Halifax Medical Center - Daytona Beach
Broward General Medical Center Cancer Center
West Florida Cancer Institute at West Florida Hospital - Pensacola
Piedmont Hospital
Northside Hospital Cancer Center
Saint Joseph's Hospital of Atlanta
CCOP - Atlanta Regional
Augusta Oncology Associates - Walton Way
WellStar Cobb Hospital
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Gwinnett Medical Center
Kennestone Cancer Center at Wellstar Kennestone Hospital
Southern Regional Medical Center
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Tripler Army Medical Center
Hematology Oncology Associates of Eastern Idaho
Saint Anthony's Hospital at Saint Anthony's Health Center
Rush-Copley Cancer Care Center
Decatur Memorial Hospital Cancer Care Institute
Elmhurst Memorial Hospital
Veterans Affairs Medical Center - Hines
Joliet Oncology-Hematology Associates, Limited - West
La Grange Memorial Hospital
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Trinity Medical Center - East
Good Samaritan Regional Health Center
West Suburban Center for Cancer Care
Swedish-American Regional Cancer Center
Regional Cancer Center at Memorial Medical Center
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
St. Francis Hospital and Health Centers - Beech Grove Campus
Elkhart General Hospital
Howard Community Hospital at Howard Regional Health System
Center for Cancer Therapy at LaPorte Hospital and Health Services
Saint Anthony Memorial Health Centers
Reid Hospital & Health Care Services, Incorporated
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
Saint Joseph Regional Medical Center
Hematology Oncology Associates of the Quad Cities
St. Luke's Hospital
Cedar Rapids Oncology Associates
Mercy Regional Cancer Center at Mercy Medical Center
Heartland Oncology & Hematology
Genesis Regional Cancer Center at Genesis Medical Center
Genesis Medical Center - West Campus
Mercy Capitol Hospital
CCOP - Iowa Oncology Research Association
John Stoddard Cancer Center at Iowa Methodist Medical Center
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Medical Oncology and Hematology Associates at Mercy Cancer Center
Mercy Cancer Center at Mercy Medical Center - Des Moines
John Stoddard Cancer Center at Iowa Lutheran Hospital
Mercy Cancer Center at Mercy Medical Center - North Iowa
McCreery Cancer Center at Ottumwa Regional
Siouxland Hematology-Oncology Associates, LLP
Siouxland Regional Cancer Center
Mercy Medical Center - Sioux City
St. Luke's Regional Medical Center
Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
Covenant Cancer Treatment Center
Cancer Center of Kansas, PA - Chanute
Cancer Center of Kansas, PA - Dodge City
Cancer Center of Kansas, PA - El Dorado
Veterans Affairs Medical Center - Kansas City
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
Tammy Walker Cancer Center at Salina Regional Health Center
Stormont-Vail Cancer Center
Cancer Center of Kansas, PA - Wellington
Associates in Womens Health, PA - North Review
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
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Tulane Cancer Center
Louisiana State University Health Sciences Center - Monroe
Christus Schumpert Cancer Treatment Center
Veterans Affairs Medical Center - Shreveport
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
CancerCare of Maine at Eastern Maine Medial Center
MaineGeneral Medical Center - Waterville Campus
Sturdy Memorial Hospital
Cancer Research Center at Boston Medical Center
Addison Gilbert Hospital
UMASS Memorial Cancer Center - University Campus
Hickman Cancer Center at Bixby Medical Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
Battle Creek Health System Cancer Care Center
Mecosta County Medical Center
Josephine Ford Cancer Center at Henry Ford Hospital
Green Bay Oncology, Limited - Escanaba
Genesys Hurley Cancer Institute
Hurley Medical Center
CCOP - Grand Rapids
Lacks Cancer Center at Saint Mary's Health Care
Spectrum Health Hospital - Butterworth Campus
Metro Health Hospital
Van Elslander Cancer Center at St. John Hospital and Medical Center
Holland Community Hospital
Green Bay Oncology, Limited - Iron Mountain
Foote Hospital
Borgess Medical Center
West Michigan Cancer Center
Bronson Methodist Hospital
Sparrow Regional Cancer Center
Upper Michigan Cancer Center at Marquette General Hospital
MidMichigan Medical Center - Midland
Community Cancer Center of Monroe
Mercy Memorial Hospital System
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Hackley Hospital
Northern Michigan Hospital
Mercy Regional Cancer Center at Mercy Hospital
Seton Cancer Institute - Saginaw
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Munson Medical Center
St. John Macomb Hospital
MeritCare Clinic - Bemidji
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
Cancer Care Center at St. Luke's Hospital
CCOP - Duluth
Miller-Dwan Medical Center
St. Mary's - Duluth Clinic Cancer Center
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Hutchinson Area Health Care
Meeker County Memorial Hospital
Immanuel St. Joseph's Clinic
HealthEast Cancer Care at St. John's Hospital
Minnesota Oncology Hematology, PA at Maplewood Cancer Center
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Hennepin County Medical Center - Minneapolis
Chippewa County - Montevideo Hospital
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Mayo Clinic Cancer Center
CentraCare Clinic - River Campus
Coborn Cancer Center
CCOP - Metro-Minnesota
Park Nicollet Health Services
Regions Hospital Cancer Care Center
St. Joseph's Hospital
United Hospital
Saint Francis Cancer Center
Ridgeview Medical Center
Willmar Cancer Center at Rice Memorial Hospital
Minnesota Oncology Hematology, PA - Woodbury
Woodwinds Health Campus
University of Mississippi Medical Center
Saint Francis Medical Center
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Ellis Fischel Cancer Center at University of Missouri - Columbia
Capital Region Cancer Center
Freeman Cancer Institute at Freeman Health System
CCOP - Kansas City
Missouri Baptist Cancer Center
Arch Medical Services, Incorporated at Center for Cancer Care Research
CCOP - St. Louis-Cape Girardeau
David C. Pratt Cancer Center at St. John's Mercy
CCOP - Cancer Research for the Ozarks
St. John's Regional Health Center
Hulston Cancer Center at Cox Medical Center South
CCOP - Montana Cancer Consortium
Hematology-Oncology Centers of the Northern Rockies - Billings
Northern Rockies Radiation Oncology Center
St. Vincent Healthcare
Billings Clinic Cancer Center
Deaconess Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
St. James Community Hospital
Big Sky Oncology
Great Falls Clinic
Sletten Regional Cancer Institute at Benefis Healthcare
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Medical Oncology
Kalispell Regional Medical Center
Community Medical Center
Guardian Oncology and Center for Wellness
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Good Samaritan Cancer Center at Good Samaritan Hospital
Cancer Resource Center - Lincoln
CCOP - Missouri Valley Cancer Consortium
Methodist Cancer Center at Methodist Hospital - Omaha
Immanuel Medical Center
Alegant Health Cancer Center at Bergan Mercy Medical Center
Creighton University Medical Center
University Medical Center of Southern Nevada
CCOP - Nevada Cancer Research Foundation
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Overlook Hospital
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Veterans Affairs Medical Center - Buffalo
Finger Lakes Hematology and Oncology
Adirondack Cancer Care - Glens Falls
CCOP - North Shore University Hospital
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Tucker Center for Cancer Care at Orange Regional Medical Center
Winthrop University Hospital
Long Island Jewish Medical Center
Interlakes Oncology/Hematology PC
James P. Wilmot Cancer Center at University of Rochester Medical Center
SUNY Upstate Medical University Hospital
Wayne Memorial Hospital, Incorporated
Lenoir Memorial Cancer Center
Rutherford Hospital
Zimmer Cancer Center at New Hanover Regional Medical Center
Bismarck Cancer Center
Medcenter One Hospital Cancer Care Center
Mid Dakota Clinic, PC
St. Alexius Medical Center Cancer Center
Dakota Cancer Institute at Dakota Clinic - South University
CCOP - MeritCare Hospital
MeritCare Broadway
McDowell Cancer Center at Akron General Medical Center
Wood County Oncology Center
Mercy Cancer Center at Mercy Medical Center
Adena Regional Medical Center
Charles M. Barrett Cancer Center at University Hospital
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Clinic Taussig Cancer Center
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Riverside Cancer Services
Mount Carmel Health - West Hospital
Doctors Hospital at Ohio Health
Grandview Hospital
Good Samaritan Hospital
Samaritan North Cancer Care Center
Veterans Affairs Medical Center - Dayton
CCOP - Dayton
Grady Memorial Hospital
Blanchard Valley Medical Associates
Fremont Memorial Hospital
Community Oncology Group at Cleveland Clinic Cancer Center
Kenton Oncology, Incorporated
Charles F. Kettering Memorial Hospital
Fairfield Medical Center
St. Rita's Medical Center
Lima Memorial Hospital
MedCentral - Mansfield Hospital
Strecker Cancer Center at Marietta Memorial Hospital
St. Luke's Hospital
Northwest Ohio Oncology Center
Middletown Regional Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
St. Charles Mercy Hospital
Toledo Clinic - Oregon
Firelands Regional Medical Center
North Coast Cancer Care, Incorporated
Mercy Medical Center
Community Hospital of Springfield and Clark County
Flower Hospital Cancer Center
Toledo Hospital
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
Toledo Clinic, Incorporated - Main Clinic
UVMC Cancer Care Center at Upper Valley Medical Center
Fulton County Health Center
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Cleveland Clinic - Wooster
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Tod Children's Hospital - Forum Health
Genesis - Good Samaritan Hospital
Merle West Medical Center Cancer Treatment Center
Veterans Affairs Medical Center - Portland
Kaiser Permanente Health Care - Portland
Oregon Health & Science University Cancer Institute
Salem Hospital Regional Cancer Care Services
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Geisinger Medical Center
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
Easton Regional Cancer Center at Easton Hospital
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Lancaster General Hospital
St. Mary Regional Cancer Center
Allegheny Cancer Center at Allegheny General Hospital
Mercy Hospital Cancer Center - Scranton
Hematology and Oncology Associates of Northeastern Pennsylvania
Geisinger Medical Group - Scenery Park
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
AnMed Cancer Center
Hollings Cancer Center at Medical University of South Carolina
Bon Secours St. Francis Health System
CCOP - Greenville
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Rapid City Regional Hospital
Avera Cancer Institute
Medical X-Ray Center, PC
Sioux Valley Hospital and University of South Dakota Medical Center
Thompson Cancer Survival Center
U.T. Cancer Institute at University of Tennessee Medical Center
University of Tennessee Cancer Institute - Medical Center
Medical City Dallas Hospital
Brooke Army Medical Center
Baylor University Medical Center - Houston
Ben Taub General Hospital
Methodist Hospital
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
Veterans Affairs Medical Center - Houston
Wilford Hall Medical Center
UMC Southwest Cancer and Research Center
Veterans Affairs Medical Center - San Antonio (Murphy)
University of Texas Health Science Center at San Antonio
Cancer Therapy and Research Center
University Hospital - San Antonio
CCOP - Scott and White Hospital
American Fork Hospital
Logan Regional Hospital
Cottonwood Hospital Medical Center
McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center - East Campus
Utah Cancer Specialists at UCS Cancer Center
Huntsman Cancer Institute at University of Utah
Latter Day Saints Hospital
Martha Jefferson Hospital Cancer Care Center
Danville Regional Medical Center
Lynchburg Hematology-Oncology Clinic
Peninsula Cancer Institute - Newport News Office
Veterans Affairs Medical Center - Richmond
Auburn Regional Center for Cancer Care
St. Joseph Cancer Center
Olympic Hematology and Oncology
Providence Centralia Hospital Regional Cancer Center
St. Francis Hospital
Skagit Valley Hospital Cancer Care Center
Providence St. Peter Hospital Regional Cancer Center
Good Samaritan Cancer Center
Fred Hutchinson Cancer Research Center
Harborview Medical Center
Minor and James Medical, PLLC
Group Health Central Hospital
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Polyclinic First Hill
University Cancer Center at University of Washington Medical Center
Cancer Care Northwest - Spokane South
Rockwood Clinic Cancer Treatment Center
Providence Cancer Center at Sacred Heart Medical Center
Providence Cancer Center at Holy Family Hospital
St. Joseph Medical Center at Franciscan Health System
Allenmore Hospital
CCOP - Northwest
MultiCare Regional Cancer Center at Tacoma General Hospital
St. Clare Hospital
Wenatchee Valley Medical Center
Fox Valley Hematology and Oncology - East Grant Street
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay Oncology, Limited at St. Mary's Hospital
St. Mary's Hospital Medical Center - Green Bay
St. Vincent Hospital Regional Cancer Center
Mercy Regional Cancer Center
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
Holy Family Memorial Medical Center Cancer Care Center
Bay Area Cancer Care Center at Bay Area Medical Center
Marshfield Clinic - Marshfield Center
Green Bay Oncology, Limited - Oconto Falls
All Saints Cancer Center at Wheaton Franciscan Healthcare
Marshfield Clinic - Indianhead Center
Green Bay Oncology, Limited - Sturgeon Bay
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Welch Cancer Center at Sheridan Memorial Hospital
Allan Blair Cancer Centre at Pasqua Hospital
Saskatoon Cancer Centre at the University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.

Secondary Outcome Measures

Progression-free Survival

Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.

Confirmed and Unconfirmed Complete and Partial Responses.

Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.

Number of Patients With a Given Type and Grade of Adverse Event.

Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.

Full Information

NCT ID

NCT00045162

First Posted

September 6, 2002

Last Updated

July 3, 2018

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI), North Central Cancer Treatment Group, Cancer and Leukemia Group B

1. Study Identification

Unique Protocol Identification Number

NCT00045162

Brief Title

S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

Official Title

Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI), North Central Cancer Treatment Group, Cancer and Leukemia Group B

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.

Detailed Description

OBJECTIVES: Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide. Compare the objective response rate and progression-free survival of patients treated with these regimens. Compare the toxic effects of these regimens in these patients. Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients. Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs more than 5%). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 4 weeks. Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 3 weeks. Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this study within 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

extensive stage small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

671 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Description

100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Description

60 mg/m2 IV (over 90 min)on Days 1, 8 & 15. Q 4 weeks x 4 Cycles

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time Frame

Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.

Secondary Outcome Measure Information:

Title

Progression-free Survival

Description

Time Frame

Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.

Title

Confirmed and Unconfirmed Complete and Partial Responses.

Description

Time Frame

Every 6 weeks while on protocol treatment for a maximum of 12 weeks

Title

Number of Patients With a Given Type and Grade of Adverse Event.

Description

Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.

Time Frame

Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: