A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their 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 I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)

Conditions
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Carcinoma, Small Cell

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Small-cell lung cancer Stage of extensive disease Adequate function of major organs and systems Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: Prior chemotherapy for small-cell lung cancer Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases Superior vena cava syndrome or obstruction of any vital structure Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation Known allergy or hypersensitivity to platinum-containing drugs Pregnancy or breast-feeding Use of any investigational drug within 4 weeks before start of the study

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 and cisplatin<br>The study drug sagopilone was administered in combination with a fixed dose of cisplatin | Drug: Sagopilone (BAY86-5302, ZK 219477)<br>* Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID<br>Drug: Cisplatin<br>* 75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin |  | Phase 1: Baseline up to 3 month of treatment | 
| Phase 2: Efficacy measure |  | Phase 2: every 6 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: PK of Sagopilone + Cisplatin |  | Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion | 
| Phase 2: Duration of CR or PR | Duration of complete response (CR) or partial response (PR) as 'overall response', defined as time between first date that the measurement criteria for CR or PR as 'overall response' are met and first date that recurrence or overall response of (progressive disease) PD is documented. | every 6 weeks after start of treatment | 
| Phase 2: TTP | Time to tumor progression (TTP) is defined as the time from the date of treatment assignment to the first observation of disease progression or to the last date of a definite assessment (not status unknown), if the patient is progression-free until that assessment. | every 6 weeks after start of treatment | 
| Phase 2: PFS | Progression free survival (PFS) is defined as the time from date of treatment assignment to the first observation of disease progression or death of any cause or to the last date of a definite assessment (not status unknown), if the patient was progression-free until that assessment | every 6 weeks after start of treatment | 
| Phase 2: OS | Overall survival (OS) is defined as the time from date of treatment assignment until death from any cause or until the last date the patient is known to be alive | every 3 months after start of treatment | 

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