ClinicalTrials.gg
CompletedNCT00030433Updated Feb 15, 2013

S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

A Phase 2 interventional study of gemcitabine hydrochloride and irinotecan hydrochloride in Lung Cancer, sponsored by SWOG Cancer Research Network. Completed at 102 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan.
  • Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen.
  • Determine the overall toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.

02

Conditions studied

  • Lung Cancer

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Keywords

  • extensive stage small cell lung cancer
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 85 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)

    • Malignant pleural effusion constitutes extensive stage disease
  • Must have disease outside area of prior surgical resection or a new lesion must be present
  • Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy)

    • Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm\^3
  • WBC at least 3,000/mm\^3
  • Platelet count at least 100,000/mm\^3

Hepatic:

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN

Renal:

  • Not specified

Other:

  • 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, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for SCLC

Chemotherapy:

  • No prior systemic chemotherapy for SCLC

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for SCLC except for brain metastases

Surgery:

  • See Disease Characteristics
  • At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)
06

Study locations

102 sites
  • University of Alabama at Birmingham Comprehensive Cancer Center
    Birmingham, Alabama 35294-3300, United States
  • MBCCOP - Gulf Coast
    Mobile, Alabama 36688, United States
  • CCOP - Greater Phoenix
    Phoenix, Arizona 85006-2726, United States
  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
    Phoenix, Arizona 85012, United States
  • Veterans Affairs Medical Center - Tucson
    Tucson, Arizona 85723, United States
  • Arizona Cancer Center
    Tucson, Arizona 85724, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Veterans Affairs Medical Center - Little Rock (McClellan)
    Little Rock, Arkansas 72205, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90033-0804, United States
  • Veterans Affairs Medical Center - West Los Angeles
    Los Angeles, California 90073, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
  • Veterans Affairs Outpatient Clinic - Martinez
    Martinez, California 94553, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609-3305, United States
  • Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • University of California Davis Medical Center
    Sacramento, California 95817, United States
  • CCOP - Santa Rosa Memorial Hospital
    Santa Rosa, California 95403, United States
  • David Grant Medical Center
    Travis Air Force Base, California 94535, United States
  • University of Colorado Cancer Center
    Denver, Colorado 80010, United States
  • Veterans Affairs Medical Center - Denver
    Denver, Colorado 80220, United States
  • MBCCOP-Howard University Cancer Center
    Washington D.C., District of Columbia 20060, United States
  • CCOP - Atlanta Regional
    Atlanta, Georgia 30342-1701, United States
  • Dwight David Eisenhower Army Medical Center
    Fort Gordon, Georgia 30905-5650, United States
  • Cancer Research Center of Hawaii
    Honolulu, Hawaii 96813-2424, United States
  • Tripler Army Medical Center
    Honolulu, Hawaii 96859-5000, United States
  • MBCCOP - University of Illinois at Chicago
    Chicago, Illinois 60612-7323, United States
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    Chicago, Illinois 60612, United States
  • CCOP - Central Illinois
    Decatur, Illinois 62526, United States
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    Hines, Illinois 60141, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160-7390, United States
  • CCOP - Wichita
    Wichita, Kansas 67214-3882, United States
  • Veterans Affairs Medical Center - Wichita
    Wichita, Kansas 67218, United States
  • Veterans Affairs Medical Center - Lexington
    Lexington, Kentucky 40502-2236, United States
  • Albert B. Chandler Medical Center, University of Kentucky
    Lexington, Kentucky 40536-0084, United States
  • MBCCOP - LSU Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Tulane University School of Medicine
    New Orleans, Louisiana 70112, United States
  • Veterans Affairs Medical Center - New Orleans
    New Orleans, Louisiana 70112, United States
  • Louisiana State University Health Sciences Center - Shreveport
    Shreveport, Louisiana 71130-3932, United States
  • Veterans Affairs Medical Center - Shreveport
    Shreveport, Louisiana 71130, United States
  • Boston Medical Center
    Boston, Massachusetts 02118-2393, United States
  • St. Elizabeth's Medical Center
    Boston, Massachusetts 02135-2997, United States
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    Jamaica Plain, Massachusetts 02130, United States
  • Veterans Affairs Medical Center - Ann Arbor
    Ann Arbor, Michigan 48105, United States
  • CCOP - Ann Arbor Regional
    Ann Arbor, Michigan 48106, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0912, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
  • Veterans Affairs Medical Center - Detroit
    Detroit, Michigan 48201-1932, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • CCOP - Grand Rapids Clinical Oncology Program
    Grand Rapids, Michigan 49503, United States
  • CCOP - Beaumont
    Royal Oak, Michigan 48073-6769, United States
  • Providence Hospital - Southfield
    Southfield, Michigan 48075-9975, United States
  • CCOP - Duluth
    Duluth, Minnesota 55805, United States
  • Veterans Affairs Medical Center - Biloxi
    Biloxi, Mississippi 39531-2410, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Veterans Affairs Medical Center - Jackson
    Jackson, Mississippi 39216, United States
  • Keesler Medical Center - Keesler AFB
    Keesler Air Force Base, Mississippi 39534-2576, United States
  • Veterans Affairs Medical Center - Kansas City
    Kansas City, Missouri 64128, United States
  • CCOP - Kansas City
    Kansas City, Missouri 64131, United States
  • CCOP - Cancer Research for the Ozarks
    Springfield, Missouri 65807, United States
  • St. Louis University Health Sciences Center
    St Louis, Missouri 63110, United States
  • CCOP - St. Louis-Cape Girardeau
    St Louis, Missouri 63141, United States
  • CCOP - Montana Cancer Consortium
    Billings, Montana 59101, United States
  • Veterans Affairs Medical Center - Albuquerque
    Albuquerque, New Mexico 87108-5138, United States
  • MBCCOP - University of New Mexico HSC
    Albuquerque, New Mexico 87131, United States
  • Veterans Affairs Medical Center - Albany
    Albany, New York 12208, United States
  • Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • CCOP - Southeast Cancer Control Consortium
    Winston-Salem, North Carolina 27104-4241, United States
  • Veterans Affairs Medical Center - Cincinnati
    Cincinnati, Ohio 45220-2288, United States
  • Barrett Cancer Center
    Cincinnati, Ohio 45267-0501, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195-9001, United States
  • CCOP - Columbus
    Columbus, Ohio 43206, United States
  • Arthur G. James Cancer Hospital - Ohio State University
    Columbus, Ohio 43210-1240, United States
  • Veterans Affairs Medical Center - Dayton
    Dayton, Ohio 45428, United States
  • CCOP - Dayton
    Kettering, Ohio 45429, United States
  • Oklahoma Medical Research Foundation
    Oklahoma City, Oklahoma 73104, United States
  • Veterans Affairs Medical Center - Oklahoma City
    Oklahoma City, Oklahoma 73104, United States
  • Veterans Affairs Medical Center - Portland
    Portland, Oregon 97207, United States
  • CCOP - Columbia River Program
    Portland, Oregon 97225, United States
  • OHSU Cancer Institute
    Portland, Oregon 97239, United States
  • Veterans Affairs Medical Center - Charleston
    Charleston, South Carolina 29401-5799, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425-0721, United States
  • CCOP - Greenville
    Greenville, South Carolina 29615, United States
  • CCOP - Upstate Carolina
    Spartanburg, South Carolina 29303, United States
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234-6200, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555-0565, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Veterans Affairs Medical Center - Houston
    Houston, Texas 77030, United States
  • Texas Tech University Health Science Center
    Lubbock, Texas 79415, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78284-7845, United States
  • Veterans Affairs Medical Center - San Antonio (Murphy)
    San Antonio, Texas 78284, United States
  • Veterans Affairs Medical Center - Temple
    Temple, Texas 76504, United States
  • CCOP - Scott and White Hospital
    Temple, Texas 76508, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112-5550, United States
  • Veterans Affairs Medical Center - Salt Lake City
    Salt Lake City, Utah 84148, United States
  • Eastern Virginia Medical School
    Norfolk, Virginia 23510-1115, United States
  • CCOP - Virginia Mason Research Center
    Seattle, Washington 98101, United States
  • Swedish Cancer Institute
    Seattle, Washington 98104, United States
  • Veterans Affairs Medical Center - Seattle
    Seattle, Washington 98108, United States

Showing the first 100 of 102 sites.

07

References and documents

Publications

  • Akerley W, McCoy J, Hesketh PJ, Goodwin JW, Bearden JD, Atkins JN, Chansky K, Crowley JJ, Gandara DR; SWOG. Gemcitabine and irinotecan for patients with untreated extensive stage small cell lung cancer: SWOG 0119. J Thorac Oncol. 2007 Jun;2(6):526-30. doi: 10.1097/JTO.0b013e318060d2dc. PubMed 17545848 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00030433
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jan 2002
Primary completion
Feb 2007
Completion
Nov 2008
Last update
Feb 15, 2013

Study contacts

Wallace L. Akerley, MD
study chair · Boston Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Gemcitabine · Irinotecan

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