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

NCT00320359 | Completed Phase 3

• 1 other identifier: 104864-A/479
• Study Type: interventional
• Target: 700
• Locations: 2 countries
• Sites: 79

Brief Summary

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

Conditions

Lung Cancer, Small Cell

Keywords

First-line Cisplatin; Small Cell Lung Cancer; topotecan; etoposide; Extensive Disease

Outcome Measures

Primary Outcomes (1)

• Median overall survival time of participants

  Up to 1 year after randomization of the last patient

Secondary Outcomes (20)

• 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

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3

Drug: Intravenous etoposide/cisplatin

Arm B

EXPERIMENTAL

Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5

Drug: Intravenous topotecan/cisplatin

Interventions

Intravenous topotecan/cisplatin DRUG

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.

Arm B

Intravenous etoposide/cisplatin DRUG

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.

Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (79)

GSK Investigational Site

Bludesch, A-6719, Austria

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GSK Investigational Site

Klagenfurt, A-9020, Austria

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GSK Investigational Site

Linz, A-4020, Austria

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GSK Investigational Site

Vienna, A-1140, Austria

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GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, 76137, Germany

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GSK Investigational Site

Löwenstein, Baden-Wurttemberg, 74245, Germany

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

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GSK Investigational Site

Wangen, Baden-Wurttemberg, 88239, Germany

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GSK Investigational Site

Bayreuth, Bavaria, 95445, Germany

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GSK Investigational Site

Munich, Bavaria, 80336, Germany

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GSK Investigational Site

Nuremberg, Bavaria, 90340, Germany

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GSK Investigational Site

Passau, Bavaria, 94032, Germany

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GSK Investigational Site

Regensburg, Bavaria, 93049, Germany

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GSK Investigational Site

Rosenheim, Bavaria, 83022, Germany

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GSK Investigational Site

Cottbus, Brandenburg, 03048, Germany

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GSK Investigational Site

Frankfurt (Oder), Brandenburg, 15236, Germany

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GSK Investigational Site

Bremen, City state Bremen, 28325, Germany

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GSK Investigational Site

Hamburg, Hamburg, 20246, Germany

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GSK Investigational Site

Hamburg, Hamburg, 21075, Germany

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GSK Investigational Site

Hamburg, Hamburg, 22043, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60431, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 65929, Germany

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GSK Investigational Site

Giessen, Hesse, 35392, Germany

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GSK Investigational Site

Greifenstein, Hesse, 35753, Germany

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GSK Investigational Site

Kassel, Hesse, 34125, Germany

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GSK Investigational Site

Limburg an der Lahn, Hesse, 65549, Germany

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GSK Investigational Site

Marburg, Hesse, 35043, Germany

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GSK Investigational Site

Offenbach, Hesse, 63069, Germany

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GSK Investigational Site

Wiesbaden, Hesse, 65199, Germany

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GSK Investigational Site

Göttingen, Lower Saxony, 37075, Germany

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GSK Investigational Site

Leer, Lower Saxony, 26789, Germany

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GSK Investigational Site

Stade, Lower Saxony, 21680, Germany

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GSK Investigational Site

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

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GSK Investigational Site

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

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GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18057, Germany

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GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18059, Germany

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GSK Investigational Site

Stralsund, Mecklenburg-Vorpommern, 18437, Germany

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GSK Investigational Site

Waren, Mecklenburg-Vorpommern, 17192, Germany

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GSK Investigational Site

Bielefeld, North Rhine-Westphalia, 33604, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

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GSK Investigational Site

Bonn, North Rhine-Westphalia, 53111, Germany

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GSK Investigational Site

Bonn, North Rhine-Westphalia, 53113, Germany

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GSK Investigational Site

Bonn, North Rhine-Westphalia, 53177, Germany

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GSK Investigational Site

Coesfeld, North Rhine-Westphalia, 48653, Germany

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GSK Investigational Site

Cologne, North Rhine-Westphalia, 50924, Germany

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GSK Investigational Site

Cologne, North Rhine-Westphalia, 50931, Germany

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GSK Investigational Site

Dorsten, North Rhine-Westphalia, 46282, Germany

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GSK Investigational Site

Duisburg, North Rhine-Westphalia, 47166, Germany

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GSK Investigational Site

Duisburg, North Rhine-Westphalia, 47228, Germany

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GSK Investigational Site

Hamm, North Rhine-Westphalia, 59071, Germany

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GSK Investigational Site

Hemer, North Rhine-Westphalia, 58675, Germany

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GSK Investigational Site

Herne, North Rhine-Westphalia, 44625, Germany

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GSK Investigational Site

Krefeld, North Rhine-Westphalia, 47798, Germany

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GSK Investigational Site

Oberhausen, North Rhine-Westphalia, 46145, Germany

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GSK Investigational Site

Velbert, North Rhine-Westphalia, 42551, Germany

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GSK Investigational Site

Wuppertal, North Rhine-Westphalia, 42283, Germany

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GSK Investigational Site

Koblenz, Rhineland-Palatinate, 56073, Germany

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GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

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GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

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GSK Investigational Site

Chemnitz, Saxony, 09113, Germany

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GSK Investigational Site

Leipzig, Saxony, 04207, Germany

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GSK Investigational Site

Plauen, Saxony, 08529, Germany

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GSK Investigational Site

Halle, Saxony-Anhalt, 06114, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39120, Germany

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GSK Investigational Site

Borstel, Schleswig-Holstein, 23845, Germany

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GSK Investigational Site

Flensburg, Schleswig-Holstein, 24939, Germany

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GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

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GSK Investigational Site

Berlin, State of Berlin, 12200, Germany

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GSK Investigational Site

Berlin, State of Berlin, 12559, Germany

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GSK Investigational Site

Berlin, State of Berlin, 13125, Germany

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GSK Investigational Site

Berlin, State of Berlin, 13353, Germany

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GSK Investigational Site

Berlin, State of Berlin, 13585, Germany

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GSK Investigational Site

Berlin, State of Berlin, 14089, Germany

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GSK Investigational Site

Berlin, State of Berlin, 14109, Germany

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GSK Investigational Site

Erfurt, Thuringia, 99089, Germany

Location

GSK Investigational Site

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: August 1, 2002
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

AU (4); DE (75)