Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

Detailed Description
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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
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Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

Conditions
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Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Sagopilone (BAY86-5302, ZK 219477)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proven Small-cell lung cancer (SCLC) Stage of extensive disease defined by the presence of distant metastases At least 1 unidimensionally measureable lesion WHO performance status 0 to 1 No previous SCLC-related chemotherapy No previous SCLC-related surgery No previous radiotherapy (excepting for brain metastasis) Adequate function of major organs and systems Nervous system No Grade 2 or greater peripheral neuropathy Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No arrythmia needing continuous treatment No other uncontrolled concurrent illness Exclusion Criteria: Superior vena cava syndrome or obstruction of any vital structure Untreated malignant hypercalcemia Pleural effusion as the only manifestation of disease Extensive disease amenable to radiation therapy Symptomatic brain metastases requiring whole brain irradiation Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sagopilone<br> | Drug: Sagopilone (BAY86-5302, ZK 219477)<br>* Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment according to the modRECIST (complete response or partial response) |  | Every 2 cycles until tumor progression i.e. approximately every 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of complete or partial tumor response |  | Every 2 cycles until tumor progression i.e. approximately every 6 weeks | 
| Time to tumor progression |  | Every 2 cycles until tumor progression i.e. approximately every 6 weeks | 
| Number of participants with adverse events |  | Approximately 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sagopilone, Epothilone, SCLC, Small Cell Lung Cancer, Lung Cancer