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

February 27, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bludesch, Austria, A-6719
        • GSK Investigational Site
      • Klagenfurt, Austria, A-9020
        • GSK Investigational Site
      • Linz, Austria, A-4020
        • GSK Investigational Site
      • Vienna, Austria, A-1140
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 14109
        • GSK Investigational Site
      • Berlin, Germany, 12559
        • GSK Investigational Site
      • Berlin, Germany, 12200
        • GSK Investigational Site
      • Berlin, Germany, 13585
        • GSK Investigational Site
      • Berlin, Germany, 14089
        • GSK Investigational Site
      • Bremen, Germany, 28325
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 21075
        • GSK Investigational Site
      • Hamburg, Germany, 22043
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • GSK Investigational Site
      • Karlsruhe, Baden-Wuerttemberg, Germany, 76137
        • GSK Investigational Site
      • Loewenstein, Baden-Wuerttemberg, Germany, 74245
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • GSK Investigational Site
      • Wangen, Baden-Wuerttemberg, Germany, 88239
        • GSK Investigational Site
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80336
        • GSK Investigational Site
      • Nuernberg, Bayern, Germany, 90340
        • GSK Investigational Site
      • Passau, Bayern, Germany, 94032
        • GSK Investigational Site
      • Regensburg, Bayern, Germany, 93049
        • GSK Investigational Site
      • Rosenheim, Bayern, Germany, 83022
        • GSK Investigational Site
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • GSK Investigational Site
      • Frankfurt/Oder, Brandenburg, Germany, 15236
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 65929
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60431
        • GSK Investigational Site
      • Giessen, Hessen, Germany, 35392
        • GSK Investigational Site
      • Greifenstein, Hessen, Germany, 35753
        • GSK Investigational Site
      • Kassel, Hessen, Germany, 34125
        • GSK Investigational Site
      • Limburg, Hessen, Germany, 65549
        • GSK Investigational Site
      • Marburg, Hessen, Germany, 35043
        • GSK Investigational Site
      • Offenbach, Hessen, Germany, 63069
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65199
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17487
        • GSK Investigational Site
      • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
        • GSK Investigational Site
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • GSK Investigational Site
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • GSK Investigational Site
      • Stralsund, Mecklenburg-Vorpommern, Germany, 18437
        • GSK Investigational Site
      • Waren, Mecklenburg-Vorpommern, Germany, 17192
        • GSK Investigational Site
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • GSK Investigational Site
      • Leer, Niedersachsen, Germany, 26789
        • GSK Investigational Site
      • Stade, Niedersachsen, Germany, 21680
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Germany, 33604
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53113
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53177
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53111
        • GSK Investigational Site
      • Coesfeld, Nordrhein-Westfalen, Germany, 48653
        • GSK Investigational Site
      • Dorsten, Nordrhein-Westfalen, Germany, 46282
        • GSK Investigational Site
      • Duisburg, Nordrhein-Westfalen, Germany, 47166
        • GSK Investigational Site
      • Duisburg, Nordrhein-Westfalen, Germany, 47228
        • GSK Investigational Site
      • Hamm, Nordrhein-Westfalen, Germany, 59071
        • GSK Investigational Site
      • Hemer, Nordrhein-Westfalen, Germany, 58675
        • GSK Investigational Site
      • Herne, Nordrhein-Westfalen, Germany, 44625
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 50924
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 50931
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Oberhausen, Nordrhein-Westfalen, Germany, 46145
        • GSK Investigational Site
      • Velbert, Nordrhein-Westfalen, Germany, 42551
        • GSK Investigational Site
      • Wuppertal, Nordrhein-Westfalen, Germany, 42283
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56073
        • GSK Investigational Site
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09113
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04207
        • GSK Investigational Site
      • Plauen, Sachsen, Germany, 08529
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle/Saale, Sachsen-Anhalt, Germany, 06114
        • GSK Investigational Site
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • GSK Investigational Site
    • Schleswig-Holstein
      • Borstel, Schleswig-Holstein, Germany, 23845
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24939
        • GSK Investigational Site
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • GSK Investigational Site
    • Thueringen
      • Erfurt, Thueringen, Germany, 99089
        • GSK Investigational Site
      • Jena, Thueringen, Germany, 07747
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3
Drug: Intravenous etoposide/cisplatin

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.
Experimental: Arm B
Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
Drug: Intravenous topotecan/cisplatin

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104864-A/479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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