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 which combination chemotherapy regimen is more effective in treating
extensive-stage small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two combination
chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
- Evaluate the response frequency of patients with extensive stage small cell lung cancer
treated with topotecan, cisplatin, and etoposide and with irinotecan, cisplatin, and
etoposide.
- Evaluate the duration of response and survival of patients treated with these regimens.
- To investigate the occurrence of various breast cancer resistance protein (BCRP)
alleles in patients receiving topoisomerase 1 inhibitors and their impact on clinical
response and toxicity.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I (PET): Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3;
etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on
days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and
continuing until blood counts recover.
- Arm II (PIE): Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60
minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
ACTUAL ACCRUAL: A total of 140 patients were accrued for this study.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware 19958, United States
CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States
Medical Center of Central Georgia, Macon, Georgia 31208, United States
Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States
Hematology & Oncology Care, Moline, Illinois 61265, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois 61265, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields, Illinois 60461, United States
Swedish-American Regional Cancer Center, Rockford, Illinois 61104-2315, 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
Bettendorf, Iowa 52722, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, 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
Associates in Womens Health, PA - North Review, Wichita, Kansas 67203, 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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
Union Hospital Cancer Program at Union Hospital, Elkton MD, Maryland 21921, United States
Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland 21701, United States
Borgess Medical Center, Kalamazoo, Michigan 49001, United States
Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey 08822, United States
CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States
Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey 08690, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey 08053, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey 08043, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey 08043, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York 10466, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio 44309-2090, United States
Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States
St. Rita's Medical Center, Lima, Ohio 45801, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania 19010, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center, East Stroudsburg, Pennsylvania 18301, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC, Lemoyne, Pennsylvania 17043, United States
Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States
Hematology and Oncology Associates of Northeastern Pennsylvania, Scranton, Pennsylvania 18510, United States
Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania 18501, United States
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center, Upland, Pennsylvania 19013, United States
Chester County Hospital, West Chester, Pennsylvania 19380, 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 57117-5039, United States
Regional Cancer Center at Sacred Heart Hospital, Eau Claire, Wisconsin 54701, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin 54601, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States