Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer

Study Overview
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Brief Summary
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Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer

Official Title
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An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer

Conditions
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Lung Cancer, Small Cell

Intervention / Treatment
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* Drug: Intravenous topotecan/cisplatin
* Drug: Intravenous etoposide/cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evaluable extensive small cell lung cancer, extensive disease. Eastern Cooperative Oncology Group (ECOG) performance status < 2. Life expectancy > 3 months. Fit to receive any of the treatments. No prior chemotherapy. Written informed consent. Exclusion Criteria: Extensive disease treatable with radiotherapy. Past or current history of other malignant disease. Prior chemotherapy. Pregnancy, lactating or lack of effective contraception. Concurrent severe medical problems other than small cell lung cancer. Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3 | Drug: Intravenous etoposide/cisplatin<br>* Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid. Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3.<br>|
| Experimental: Arm B<br>Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5 | Drug: Intravenous topotecan/cisplatin<br>* Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5. Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median overall survival time of participants |  | Up to 1 year after randomization of the last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with one year survival rate of the participants |  | Up to 1 year after randomization of the last patient | 
| Median time of disease progression |  | up to 1 year after randomization of the last patient | 
| Median time to event (progressive disease or death) of participants |  | Up to 1 year after randomization of the last patient | 
| Median time to response to chemotherapy |  | Up to 1 year after randomization of the last patient | 
| Median response duration |  | Up to 1 year after randomization of the last patient | 
| Number of participants with objective response |  | Up to 1 year after randomization of the last patient | 
| Mean lung cancer symptom score (LCSS) |  | Up to 18 weeks | 
| Mean eastern cooperative oncology group (ECOG) score |  | Up to 18 weeks | 
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) |  | Up to 1 year after randomization of the last patient | 
| Mean change from Baseline in hemoglobin value |  | Baseline and up to 18 weeks | 
| Mean change from Baseline in leukocytes, neutrophils and platelets count |  | Baseline and up to 18 weeks | 
| Mean change from Baseline in red blood cells (RBCs) |  | Baseline and up to 18 weeks | 
| Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH) |  | Baseline and up to 18 weeks | 
| Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea |  | Baseline and up to 18 weeks | 
| Mean change from Baseline in Creatinine and Total bilirubin |  | Baseline and up to 18 weeks | 
| Mean change from Baseline in Creatinine clearance |  |  | 
| Mean change from Baseline in total protein |  | Baseline and up to 18 weeks | 
| Number of participants with abnormal urinalysis results |  |  | 
| Mean change from Baseline in weight |  | Baseline and up to 18 weeks | 
| Mean change from Baseline in Body surface area |  | Baseline and up to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First-line Cisplatin, Small Cell Lung Cancer, topotecan, etoposide, Extensive Disease