Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride. Secondary Determine the safety and toxic effects of this drug in these patients. Determine the recurrence-free survival of patients treated with this drug. Determine time to response and tumor response in patients treated with this drug. Determine the quality of life of patients treated with this drug. OUTLINE: This is a non-randomized, multicenter study. Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter. Patients are followed at 7-14 days and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Official Title
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The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer (SCLC) Recurrent extensive stage disease No mixed histology Measurable disease At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI Sensitive disease Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy) Eligible for high-dose chemotherapy No symptomatic brain metastases affecting performance status PATIENT CHARACTERISTICS: Age 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy At least 2 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL Hematocrit > 35% (without transfusion) Hepatic Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal* Alkaline phosphatase ≤ 2 times normal* Bilirubin ≤ 2.0 mg/dL Albumin > 2.5 g/dL Hepatitis B surface antigen negative No significant hepatic disease Note: *≤ 5 times upper limit of normal if liver metastases are present Renal Creatinine clearance ≥ 40 mL/min Cardiovascular No history of cardiac arrhythmias No congestive heart failure No ischemic heart disease No stroke or other embolic disease requiring daily treatment that would preclude study participation Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation HIV negative No known seizure disorder No active infection requiring systemic therapy within the past 2 weeks No known hypersensitivity to topotecan hydrochloride No medical or psychiatric condition that would preclude study participation No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC No prior topotecan hydrochloride Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 2 months since prior investigational agent No other concurrent investigational agent

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: topotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toxic effects |  |  | 
| Recurrence-free survival |  |  | 
| Time to response and tumor response |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extensive stage small cell lung cancer, recurrent small cell lung cancer