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

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057837

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Biological: filgrastim Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Drug: topotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Irinotecan U 101440E Etoposide phosphate Topotecan hydrochloride Filgrastim Topotecan Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	March 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive topotecan 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.	Biological: filgrastim Given subcutaneously Drug: cisplatin Given IV Drug: etoposide Given IV (arm I) or orally (arm II) Drug: topotecan hydrochloride Given IV
Arm II: Experimental 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.	Drug: cisplatin Given IV Drug: etoposide Given IV (arm I) or orally (arm II) Drug: irinotecan hydrochloride Given IV

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

Correlate the occurrence of various BRCP polymorphisms with clinical response and toxicity in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive topotecan 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: 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.

PROJECTED ACCRUAL: A total of 60-140 patients (30-70 per treatment arm) will be accrued for this study within 7-16 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of extensive stage small cell lung cancer
Measurable disease
CNS metastases allowed if previously treated and with no advancing symptoms

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-3

Life expectancy

Not specified

Hematopoietic

WBC at least 4,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

Creatinine clearance at least 30 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent epoetin alfa allowed provided treatment was initiated before study entry

Chemotherapy

No prior chemotherapy for this disease

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for lung cancer
Prior radiotherapy for brain metastases allowed

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057837

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Locations

United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
United States, Illinois

Moline, Illinois, United States, 61265
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801

Moline, Illinois, United States, 61265

Moline, Illinois, United States, 61265
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801

Moline, Illinois, United States, 61265
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields, Illinois, United States, 60461
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States, 61265
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Clarian Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101

Bettendorf, Iowa, United States, 52722
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Maryland
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States, 21701
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
United States, New York
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
United States, Pennsylvania
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
Upland, Pennsylvania, United States, 19013
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne, Pennsylvania, United States, 17043
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, United States, 18510
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wisconsin
Regional Cancer Center at Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Joseph Aisner, MD	Cancer Institute of New Jersey
Investigator:	Eric H. Rubin, MD	Cancer Institute of New Jersey

Responsible Party:	ECOG Group Chair's Office ( Robert L. Comis )
Study ID Numbers:	CDR0000276590, ECOG-5501
Study First Received:	April 7, 2003
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00057837 History of Changes
Health Authority:	United States: Federal Government