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

Phase 2

Completed

Conditions: Extensive Stage Small Cell Lung Cancer

Interventions: Biological: G-CSF
Drug: Cisplatin
Drug: Irinotecan
Drug: Etoposide
Drug: Topotecan

Registration Number: NCT00057837

Lead Sponsor: Eastern Cooperative Oncology Group

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 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.

Detailed Description: OBJECTIVES:

Primary

* 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 toxic effects of these regimens in these patients.

* Evaluate the duration of response and survival of patients treated with these regimens.

Secondary

* 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PET (Topotecan/Etoposide/Cisplatin/G-CSF)	G-CSF	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.
PIE (Irinotecan/Cisplatin/Etoposide)	Irinotecan	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 of each cycle.
PET (Topotecan/Etoposide/Cisplatin/G-CSF)	Cisplatin	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.
PET (Topotecan/Etoposide/Cisplatin/G-CSF)	Etoposide	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.
PET (Topotecan/Etoposide/Cisplatin/G-CSF)	Topotecan	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.
PIE (Irinotecan/Cisplatin/Etoposide)	Cisplatin	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 of each cycle.
PIE (Irinotecan/Cisplatin/Etoposide)	Etoposide	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 of each cycle.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)	Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.	Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

Secondary Outcome Measures

Name	Time	Method
Duration of Response	Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.	Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started.
Overall Survival	Assessed every 3 months for 2 years, then every 6 months for 1 years	Overall survival is defined as the time from randomization to death.

Trial Locations

Locations (78): Elkhart General Hospital
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Elkhart, Indiana, United States
Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, United States
St. Luke's Regional Medical Center
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Sioux City, Iowa, United States
Bronson Methodist Hospital
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Kalamazoo, Michigan, United States
CCOP - Carle Cancer Center
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Urbana, Illinois, United States
Saint Joseph Regional Medical Center
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South Bend, Indiana, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
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Voorhees, New Jersey, United States
Summa Center for Cancer Care at Akron City Hospital
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Akron, Ohio, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸
New Brunswick, New Jersey, United States
Howard Community Hospital
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Kokomo, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸
Sioux City, Iowa, United States
Southwest Medical Center
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Liberal, Kansas, United States
Cancer Center of Kansas, PA - Kingman
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Kingman, Kansas, United States
Cancer Center of Kansas, PA - Wellington
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Wellington, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
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Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Chanute
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Chanute, Kansas, United States
Cancer Center of Kansas, PA - Winfield
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Winfield, Kansas, United States
CCOP - Wichita
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Wichita, Kansas, United States
CCOP - Northern New Jersey
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Hackensack, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
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Voorhees, New Jersey, United States
CCOP - Christiana Care Health Services
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Newark, Delaware, United States
Sanford Cancer Center at Sanford USD Medical Center
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Sioux Falls, South Dakota, United States
St. Rita's Medical Center
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Lima, Ohio, United States
Avera Cancer Institute
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Sioux Falls, South Dakota, United States
Marshfield Clinic - Marshfield Center
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Marshfield, Wisconsin, United States
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
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Upland, Pennsylvania, United States
Case Comprehensive Cancer Center
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Cleveland, Ohio, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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La Crosse, Wisconsin, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
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East Stroudsburg, Pennsylvania, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC
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Lemoyne, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
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Paoli, Pennsylvania, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
🇺🇸
Scranton, Pennsylvania, United States
Marshfield Clinic - Weston Center
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Weston, Wisconsin, United States
Bryn Mawr Hospital
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Bryn Mawr, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
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Scranton, Pennsylvania, United States
Chester County Hospital
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West Chester, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
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Reading, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, United States
Regional Cancer Center at Sacred Heart Hospital
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Eau Claire, Wisconsin, United States
Marshfield Clinic - Indianhead Center
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Rice Lake, Wisconsin, United States
CCOP - MainLine Health
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Wynnewood, Pennsylvania, United States
Tunnell Cancer Center at Beebe Medical Center
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Lewes, Delaware, United States
Baptist Cancer Institute - Jacksonville
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Jacksonville, Florida, United States
Hematology & Oncology Care
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Moline, Illinois, United States
Rush-Copley Cancer Care Center
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Aurora, Illinois, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, United States
Medical Center of Central Georgia
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Macon, Georgia, United States
Joliet Oncology-Hematology Associates, Limited - West
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Joliet, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Moline, Illinois, United States
Swedish-American Regional Cancer Center
🇺🇸
Rockford, Illinois, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
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Olympia Fields, Illinois, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
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La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
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Michigan City, Indiana, United States
Clarian Arnett Cancer Care
🇺🇸
Lafayette, Indiana, United States
Memorial Hospital of South Bend
🇺🇸
South Bend, Indiana, United States
Mercy Medical Center - Sioux City
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Sioux City, Iowa, United States
CCOP - Northern Indiana CR Consortium
🇺🇸
South Bend, Indiana, United States
Cancer Center of Kansas, PA - El Dorado
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El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Parsons
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Parsons, Kansas, United States
Cancer Center of Kansas, PA - Newton
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Newton, Kansas, United States
Cancer Center of Kansas, PA - Pratt
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Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
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Salina, Kansas, United States
Associates in Womens Health, PA - North Review
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Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, United States
West Michigan Cancer Center
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Kalamazoo, Michigan, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸
Wichita, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
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Frederick, Maryland, United States
Borgess Medical Center
🇺🇸
Kalamazoo, Michigan, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸
Elkton, Maryland, United States
Lakeland Regional Cancer Care Center - St. Joseph
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Saint Joseph, Michigan, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
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Flemington, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
🇺🇸
Hamilton, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸
Marlton, New Jersey, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
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Bronx, New York, United States
Medical X-Ray Center, PC
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Sioux Falls, South Dakota, United States