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

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: Lung Cancer, Small Cell
• Intervention / Treatment: Drug: Intravenous etoposide/cisplatin; Drug: Intravenous topotecan/cisplatin

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

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: Small Cell Lung Cancer; etoposide; topotecan; Extensive Disease; First-line Cisplatin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Etoposide; Cisplatin; Topotecan
• Other Study ID Numbers: 104864-A/479