Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

INCLUSION CRITERIA:

Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
Disease-free for >=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and platelets >=100,000/mm3; bilirubin <= upper limit of normal; serum glutamic pyruvate transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase( AST) <=2.5 x upper limit of normal if no demonstrable liver metastases or <=5 times upper limit of normal in the presence of liver metastases; Calculated creatinine clearance >=30 using the formulas in the protocol
Age 18 and older
Strongly advised to use an accepted and effective method of contraception
Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy
Those receiving erythropoietin could continue to receive it

EXCLUSION CRITERIA:

Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases
Prior chemotherapy for this disease
Pregnant or lactating

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00057837

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 68 Locations for this study

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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, 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
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, 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, United States
Union Hospital Cancer Program at Union Hospital
Elkton Maryland, 21921, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick Maryland, 21701, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint 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, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, 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, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Mercy Hospital Cancer Center - Scranton
Scranton Pennsylvania, 18501, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton Pennsylvania, 18510, 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, 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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00057837

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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