Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Study Overview
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Brief Summary
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This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

Detailed Description
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All patients will receive weekly topotecan. Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)

Official Title
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A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Conditions
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Small Cell Lung Cancer, Carcinoma, Small Cell

Intervention / Treatment
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* Drug: Topotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen Measurable or evaluable disease Able to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney function May have received no more than 3 previous courses of radiation therapy Give written informed consent prior to study entry Exclusion Criteria: Patients with limited stage disease History of a prior malignancy within three years Female patients who are pregnant or are breast feeding Significant history of uncontrolled cardiac disease Myocardial infarction or stroke within six months Symptomatic peripheral vascular disease CNS involvement Serious active infection or underlying medical condition

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topotecan<br> | Drug: Topotecan<br>* Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.<br>* Other names: Hycamtin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall toxicity |  | 18 months | 
| time to progression |  | 18 months | 
| duration of response |  | 18 months | 
| overall survival |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Extensive stage, Small Cell Lung Cancer