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

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ClinicalTrials.gov Identifier: NCT00030433
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 15, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest 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.

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

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)
Study Start Date : January 2002
Primary Completion Date : February 2007
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


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


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


  • Not specified


  • 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


Biologic therapy:

  • No prior biologic therapy for SCLC


  • No prior systemic chemotherapy for SCLC

Endocrine therapy:

  • Not specified


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030433

  Show 102 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Wallace L. Akerley, MD Boston Medical Center

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00030433     History of Changes
Other Study ID Numbers: CDR0000069165
S0119 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Southwest Oncology Group:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors