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

Primary Purpose

Lung Cancer, Small Cell

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Intravenous topotecan/cisplatin
Intravenous etoposide/cisplatin
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer, Small Cell focused on measuring First-line Cisplatin, Small Cell Lung Cancer, topotecan, etoposide, Extensive Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
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  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Median overall survival time of participants

Secondary Outcome Measures

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

Full Information

First Posted
May 1, 2006
Last Updated
February 27, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00320359
Brief Title
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Small Cell
Keywords
First-line Cisplatin, Small Cell Lung Cancer, topotecan, etoposide, Extensive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
Intervention Type
Drug
Intervention Name(s)
Intravenous topotecan/cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous etoposide/cisplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median overall survival time of participants
Time Frame
Up to 1 year after randomization of the last patient
Secondary Outcome Measure Information:
Title
Number of participants with one year survival rate of the participants
Time Frame
Up to 1 year after randomization of the last patient
Title
Median time of disease progression
Time Frame
up to 1 year after randomization of the last patient
Title
Median time to event (progressive disease or death) of participants
Time Frame
Up to 1 year after randomization of the last patient
Title
Median time to response to chemotherapy
Time Frame
Up to 1 year after randomization of the last patient
Title
Median response duration
Time Frame
Up to 1 year after randomization of the last patient
Title
Number of participants with objective response
Time Frame
Up to 1 year after randomization of the last patient
Title
Mean lung cancer symptom score (LCSS)
Time Frame
Up to 18 weeks
Title
Mean eastern cooperative oncology group (ECOG) score
Time Frame
Up to 18 weeks
Title
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Up to 1 year after randomization of the last patient
Title
Mean change from Baseline in hemoglobin value
Time Frame
Baseline and up to 18 weeks
Title
Mean change from Baseline in leukocytes, neutrophils and platelets count
Time Frame
Baseline and up to 18 weeks
Title
Mean change from Baseline in red blood cells (RBCs)
Time Frame
Baseline and up to 18 weeks
Title
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
Title
Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea
Time Frame
Baseline and up to 18 weeks
Title
Mean change from Baseline in Creatinine and Total bilirubin
Time Frame
Baseline and up to 18 weeks
Title
Mean change from Baseline in Creatinine clearance
Title
Mean change from Baseline in total protein
Time Frame
Baseline and up to 18 weeks
Title
Number of participants with abnormal urinalysis results
Title
Mean change from Baseline in weight
Time Frame
Baseline and up to 18 weeks
Title
Mean change from Baseline in Body surface area
Time Frame
Baseline and up to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bludesch
ZIP/Postal Code
A-6719
Country
Austria
Facility Name
GSK Investigational Site
City
Klagenfurt
ZIP/Postal Code
A-9020
Country
Austria
Facility Name
GSK Investigational Site
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
GSK Investigational Site
City
Karlsruhe
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76137
Country
Germany
Facility Name
GSK Investigational Site
City
Loewenstein
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74245
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Wangen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88239
Country
Germany
Facility Name
GSK Investigational Site
City
Bayreuth
State/Province
Bayern
ZIP/Postal Code
95445
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90340
Country
Germany
Facility Name
GSK Investigational Site
City
Passau
State/Province
Bayern
ZIP/Postal Code
94032
Country
Germany
Facility Name
GSK Investigational Site
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93049
Country
Germany
Facility Name
GSK Investigational Site
City
Rosenheim
State/Province
Bayern
ZIP/Postal Code
83022
Country
Germany
Facility Name
GSK Investigational Site
City
Cottbus
State/Province
Brandenburg
ZIP/Postal Code
03048
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt/Oder
State/Province
Brandenburg
ZIP/Postal Code
15236
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60431
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
Facility Name
GSK Investigational Site
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
GSK Investigational Site
City
Greifenstein
State/Province
Hessen
ZIP/Postal Code
35753
Country
Germany
Facility Name
GSK Investigational Site
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34125
Country
Germany
Facility Name
GSK Investigational Site
City
Limburg
State/Province
Hessen
ZIP/Postal Code
65549
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Facility Name
GSK Investigational Site
City
Offenbach
State/Province
Hessen
ZIP/Postal Code
63069
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
Facility Name
GSK Investigational Site
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17487
Country
Germany
Facility Name
GSK Investigational Site
City
Neubrandenburg
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17036
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18057
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18059
Country
Germany
Facility Name
GSK Investigational Site
City
Stralsund
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18437
Country
Germany
Facility Name
GSK Investigational Site
City
Waren
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17192
Country
Germany
Facility Name
GSK Investigational Site
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
GSK Investigational Site
City
Leer
State/Province
Niedersachsen
ZIP/Postal Code
26789
Country
Germany
Facility Name
GSK Investigational Site
City
Stade
State/Province
Niedersachsen
ZIP/Postal Code
21680
Country
Germany
Facility Name
GSK Investigational Site
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33604
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
GSK Investigational Site
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53111
Country
Germany
Facility Name
GSK Investigational Site
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53113
Country
Germany
Facility Name
GSK Investigational Site
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53177
Country
Germany
Facility Name
GSK Investigational Site
City
Coesfeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48653
Country
Germany
Facility Name
GSK Investigational Site
City
Dorsten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46282
Country
Germany
Facility Name
GSK Investigational Site
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47166
Country
Germany
Facility Name
GSK Investigational Site
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47228
Country
Germany
Facility Name
GSK Investigational Site
City
Hamm
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
59071
Country
Germany
Facility Name
GSK Investigational Site
City
Hemer
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58675
Country
Germany
Facility Name
GSK Investigational Site
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44625
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany
Facility Name
GSK Investigational Site
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47798
Country
Germany
Facility Name
GSK Investigational Site
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46145
Country
Germany
Facility Name
GSK Investigational Site
City
Velbert
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42551
Country
Germany
Facility Name
GSK Investigational Site
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42283
Country
Germany
Facility Name
GSK Investigational Site
City
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56073
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
GSK Investigational Site
City
Halle/Saale
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06114
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
GSK Investigational Site
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09113
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04207
Country
Germany
Facility Name
GSK Investigational Site
City
Plauen
State/Province
Sachsen
ZIP/Postal Code
08529
Country
Germany
Facility Name
GSK Investigational Site
City
Borstel
State/Province
Schleswig-Holstein
ZIP/Postal Code
23845
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24939
Country
Germany
Facility Name
GSK Investigational Site
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
GSK Investigational Site
City
Erfurt
State/Province
Thueringen
ZIP/Postal Code
99089
Country
Germany
Facility Name
GSK Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12559
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Facility Name
GSK Investigational Site
City
Bremen
ZIP/Postal Code
28325
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22043
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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