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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 12 weeks Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 1.5 times normal Alkaline phosphatase < 1.5 times normal Bilirubin ≤ 1.3 mg/dL Renal Creatinine ≤ 1.6 mg/dL OR Creatinine clearance ≥ 50 mL/min Cardiovascular No unstable angina No congestive heart failure No myocardial infarction within the past 3 months No life-threatening ventricular arrhythmia requiring maintenance therapy Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy 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 Radiotherapy At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 1 month since prior participation in another clinical trial using an investigational agent No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response (complete, partial, and stable disease) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to progression |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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