Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182806
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 6, 2012
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV non-small cell lung cancer.

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

Detailed Description:



  • Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan and gemcitabine.


  • Determine the median time to progression in patients treated with this regimen.

OUTLINE: This a non-randomized, open-label, multicenter study.

Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 1 month and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 16 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
Study Start Date : September 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

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

Intervention Details:
    Drug: gemcitabine hydrochloride
    IV over 30 minutes on days 2 and 9. Courses repeat every 21 days.
    Drug: irinotecan hydrochloride
    IV over 90 minutes on days 1 and 8. Courses repeat every 21 days.

Primary Outcome Measures :
  1. Objective response (complete, partial, and stable disease)

Secondary Outcome Measures :
  1. Median time to progression

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 non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:

    • Stage IIIA or IIIB disease

      • Progressive disease
    • Stage IV disease

      • Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy
  • Measurable or evaluable disease, as defined by 1 of the following criteria:

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
    • Lesions apparent on CT scan that do not meet the criterion for measurability
  • Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 12 weeks


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • AST and ALT ≤ 1.5 times normal
  • Alkaline phosphatase < 1.5 times normal
  • Bilirubin ≤ 1.3 mg/dL


  • Creatinine ≤ 1.6 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min


  • No unstable angina
  • No congestive heart failure
  • No myocardial infarction within the past 3 months
  • No life-threatening ventricular arrhythmia requiring maintenance therapy


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
  • No uncontrolled seizure disorder
  • No uncontrolled diabetes mellitus
  • No active infection requiring systemic therapy
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other unstable or serious condition


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • Prior irinotecan allowed
  • No prior gemcitabine
  • No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • More than 1 month since prior participation in another clinical trial using an investigational agent
  • No other concurrent investigational agents

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 identifier (NCT number): NCT00182806

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Nithya Ramnath, MD Roswell Park Cancer Institute

Publications of Results:
Responsible Party: Roswell Park Cancer Institute Identifier: NCT00182806     History of Changes
Other Study ID Numbers: CDR0000441226
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

Keywords provided by Roswell Park Cancer Institute:
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
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