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

Phase 3

Completed

• Conditions: Lung Cancer, Small Cell
• Interventions: Drug: Intravenous topotecan/cisplatin; Drug: Intravenous etoposide/cisplatin

• Registration Number: NCT00320359
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Intravenous topotecan/cisplatin	Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
Arm A	Intravenous etoposide/cisplatin	Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3

Primary Outcome Measures

Name	Time	Method
Median overall survival time of participants	Up to 1 year after randomization of the last patient

Secondary Outcome Measures

Name	Time	Method
Mean change from Baseline in Creatinine and Total bilirubin	Baseline and up to 18 weeks
Mean change from Baseline in Creatinine clearance
Number of participants with abnormal urinalysis results
Mean change from Baseline in weight	Baseline and up to 18 weeks
Number of participants with one year survival rate of the participants	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
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 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 Body surface area	Baseline and up to 18 weeks
Median time of disease progression	up to 1 year after randomization of the last patient
Median response duration	Up to 1 year after randomization of the last patient
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 total protein	Baseline and up to 18 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Hamburg, Germany