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

This study has been completed.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: September 15, 2005
Last updated: March 5, 2012
Last verified: March 2012

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 Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Objective response (complete, partial, and stable disease) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median time to progression [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: September 2004
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00182806     History of Changes
Other Study ID Numbers: CDR0000441226  RPCI-I-31204 
Study First Received: September 15, 2005
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on May 05, 2016