AzTrials
AzTrials

Lung CancerPhase 2NCT00030433

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

A Phase 2 study testing gemcitabine hydrochloride and irinotecan hydrochloride in people with Lung Cancer, run by SWOG Cancer Research Network at 102 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
gemcitabine hydrochloride and irinotecan hydrochloride
How many people
85 participants
Where
102 sitesUnited States
Study dates
Jan 2002to Nov 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

102 sites in 1 country.

102 sites in 1 country

United States102 sites

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0912

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Boston Medical Center

    Boston, Massachusetts, 02118-2393

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135-2997

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Barrett Cancer Center

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813-2424

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7390

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Texas Tech University Health Science Center

    Lubbock, Texas, 79415

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510-1115

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona, 85012

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Program

    Portland, Oregon, 97225

  • OHSU Cancer Institute

    Portland, Oregon, 97239

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7845

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78284

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71130

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • MBCCOP-Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

Other trials in United States

About this study

Official title: Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)

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.

Conditions
Lung Cancer
Keywords
extensive stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2002
  3. Primary completionFeb 2007
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030433
Sponsor's protocol ID
CDR0000069165
Other IDs
S0119, U10CA032102
Status last verified
Feb 2013
First submitted
14 Feb 2002
Last updated
15 Feb 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and irinotecan hydrochloride in people with Lung Cancer, run by SWOG Cancer Research Network at 102 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030433, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in