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Randomized Phase III Trial of Cisplatin (NSC-119875) and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide (NSC-141540) in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Randomized Phase III Trial of Cisplatin (NSC-119875) and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide (NSC-141540) in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)


- 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.

Inclusion Criteria


- Histologically or cytologically confirmed extensive stage small cell lung cancer

- Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear

- Brain metastases allowed if previously treated with radiotherapy and/or surgery and
are neurologically stable (i.e., no progressing symptoms and off steroids and



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- WBC at least 3,000/mm^3

- Absolute granulocyte 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 or ALT no greater than 2.5 times ULN


- Creatinine normal

- Creatinine clearance at least 50 mL/min


- 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


Biologic therapy

- No prior biologic therapy for SCLC

- No filgrastim (G-CSF) within 24 hours of chemotherapy


- No prior systemic chemotherapy for SCLC

Endocrine therapy

- See Disease Characteristics


- See Disease Characteristics

- At least 21 days since prior brain radiotherapy and recovered

- No other prior radiotherapy for SCLC


- See Disease Characteristics

- At least 21 days since prior thoracic or other major surgery and recovered


- No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital,
oxcarboxepine, or carbamazepine)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

To compare the survival of patients with extensive stage small cell lung cancer (E-SCLC) treated with cisplatin and irinotecan versus cisplatin and etoposide.

Outcome Time Frame:

0-3 years or until death

Safety Issue:


Principal Investigator

Ronald B. Natale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center


United States: Federal Government

Study ID:




Start Date:

November 2002

Completion Date:

December 2009

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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Tod Children's Hospital - Forum Health Youngstown, Ohio  44501
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
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James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
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Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
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Mecosta County Medical Center Big Rapids, Michigan  49307
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Upper Michigan Cancer Center at Marquette General Hospital Marquette, Michigan  49855
Community Cancer Center of Monroe Monroe, Michigan  48162
Mercy Memorial Hospital System Monroe, Michigan  48162
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MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Chippewa County - Montevideo Hospital Montevideo, Minnesota  56265
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Park Nicollet Health Services St. Louis Park, Minnesota  55416
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Adirondack Cancer Care - Glens Falls Glens Falls, New York  12801
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Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
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Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
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Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
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Cleveland Clinic - Wooster Wooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Kaiser Permanente Health Care - Portland Portland, Oregon  97232
St. Mary Regional Cancer Center Langhorne, Pennsylvania  19047
Bon Secours St. Francis Health System Greenville, South Carolina  29601
UMC Southwest Cancer and Research Center Lubbock, Texas  79415-3364
Cancer Therapy and Research Center San Antonio, Texas  78229
University Hospital - San Antonio San Antonio, Texas  78229
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Providence Cancer Center at Holy Family Hospital Spokane, Washington  99207
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health System Tacoma, Washington  98405-3004
Allenmore Hospital Tacoma, Washington  98411-0414
Miller-Dwan Medical Center Duluth, Minnesota  55805
Lancaster General Hospital Lancaster, Pennsylvania  17604-3555
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith, Arkansas  72903
California Cancer Center - Woodward Park Office Fresno, California  93720
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County Madisonville, Kentucky  42431
Tulane Cancer Center New Orleans, Louisiana  70112
Cancer Care Center at St. Luke's Hospital Duluth, Minnesota  55805
Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Allegheny Cancer Center at Allegheny General Hospital Pittsburgh, Pennsylvania  15212
Eastern Connecticut Hematology and Oncology Associates Norwich, Connecticut  06360
West Florida Cancer Institute at West Florida Hospital - Pensacola Pensacola, Florida  32514
Covenant Cancer Treatment Center Waterloo, Iowa  50702
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
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
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
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Flower Hospital Cancer Center Sylvania, Ohio  43560
Salem Hospital Regional Cancer Care Services Salem, Oregon  97309-5014
Hematology and Oncology Associates of Northeastern Pennsylvania Scranton, Pennsylvania  18510
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Methodist Cancer Center at Methodist Hospital - Omaha Omaha, Nebraska  68114
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Oregon Health & Science University Cancer Institute Portland, Oregon  97239-3098
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Auburn Regional Center for Cancer Care Auburn, Washington  98002
Ben Taub General Hospital Houston, Texas  77030
Methodist Hospital Houston, Texas  77030
Shasta Regional Medical Center Redding, California  96001-0853
Washington Township Hospital Fremont, California  94538
Hematology Oncology Associates of Eastern Idaho Idaho Falls, Idaho  83404
Immanuel St. Joseph's Clinic Mankato, Minnesota  56002
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Rutherford Hospital Rutherfordton, North Carolina  28139
Easton Regional Cancer Center at Easton Hospital Easton, Pennsylvania  18042
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Martha Jefferson Hospital Cancer Care Center Charlottesville, Virginia  22901
MedCentral - Mansfield Hospital Mansfield, Ohio  44903
Freeman Cancer Institute at Freeman Health System Joplin, Missouri  64803-2644
U.T. Cancer Institute at University of Tennessee Medical Center Knoxville, Tennessee  37920-2911
Huntsville Hospital Huntsville, Alabama  35807
La Grange Memorial Hospital La Grange, Illinois  60525
Cedar Valley Medical Specialists, PC - West Ridgeway Avenue Waterloo, Iowa  50702
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Arch Medical Services, Incorporated at Center for Cancer Care Research Saint Louis, Missouri  63141
Billings Clinic Cancer Center Billings, Montana  59107-5100
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
PinnacleHealth Regional Cancer Center at Polyclinic Hospital Harrisburg, Pennsylvania  17105
Rockwood Clinic Cancer Treatment Center Spokane, Washington  99204-2967
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
Halifax Medical Center - Daytona Beach Daytona Beach, Florida  32115
Woodwinds Health Campus Woodbury, Minnesota  55125
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center Dubois, Pennsylvania  15801
Desert Regional Medical Center Comprehensive Cancer Center Palm Springs, California  92262
Lynchburg Hematology-Oncology Clinic Lynchburg, Virginia  24501
Elmhurst Memorial Hospital Elmhurst, Illinois  60126
AnMed Cancer Center Anderson, South Carolina  29621
Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens, Michigan  48043
Providence Centralia Hospital Regional Cancer Center Centralia, Washington  98531
Minnesota Oncology Hematology, PA at Maplewood Cancer Center Maplewood, Minnesota  55109
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Augusta Oncology Associates - Walton Way Augusta, Georgia  30901
Heartland Oncology & Hematology Council Bluffs, Iowa  51503
Christus Schumpert Cancer Treatment Center Shreveport, Louisiana  71101
MaineGeneral Medical Center - Waterville Campus Waterville, Maine  04901
Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune, New Jersey  07754-0397
Addison Gilbert Hospital Gloucester, Massachusetts  01930
Mercy Regional Cancer Center Janesville, Wisconsin  53547
East Alabama Medical Center Opelika, Alabama  36801-5452
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Capital Region Cancer Center Jefferson City, Missouri  65101
Merle West Medical Center Cancer Treatment Center Klamath Falls, Oregon  97601
University of Tennessee Cancer Institute - Medical Center Memphis, Tennessee  38104
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston, Texas  77030
Peninsula Cancer Institute - Newport News Office Newport News, Virginia  23601