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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00320359

Collaborator

(none)

700

Enrollment

Locations

Arms

Duration (Months)

8.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer, Small Cell	Drug: Intravenous topotecan/cisplatin Drug: Intravenous etoposide/cisplatin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Median overall survival time of participants [Up to 1 year after randomization of the last patient]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bludesch		Austria	A-6719
2	GSK Investigational Site	Klagenfurt		Austria	A-9020
3	GSK Investigational Site	Linz		Austria	A-4020
4	GSK Investigational Site	Vienna		Austria	A-1140
5	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
6	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg	Germany	76137
7	GSK Investigational Site	Loewenstein	Baden-Wuerttemberg	Germany	74245
8	GSK Investigational Site	Mannheim	Baden-Wuerttemberg	Germany	68167
9	GSK Investigational Site	Wangen	Baden-Wuerttemberg	Germany	88239
10	GSK Investigational Site	Bayreuth	Bayern	Germany	95445
11	GSK Investigational Site	Muenchen	Bayern	Germany	80336
12	GSK Investigational Site	Nuernberg	Bayern	Germany	90340
13	GSK Investigational Site	Passau	Bayern	Germany	94032
14	GSK Investigational Site	Regensburg	Bayern	Germany	93049
15	GSK Investigational Site	Rosenheim	Bayern	Germany	83022
16	GSK Investigational Site	Cottbus	Brandenburg	Germany	03048
17	GSK Investigational Site	Frankfurt/Oder	Brandenburg	Germany	15236
18	GSK Investigational Site	Frankfurt	Hessen	Germany	60431
19	GSK Investigational Site	Frankfurt	Hessen	Germany	65929
20	GSK Investigational Site	Giessen	Hessen	Germany	35392
21	GSK Investigational Site	Greifenstein	Hessen	Germany	35753
22	GSK Investigational Site	Kassel	Hessen	Germany	34125
23	GSK Investigational Site	Limburg	Hessen	Germany	65549
24	GSK Investigational Site	Marburg	Hessen	Germany	35043
25	GSK Investigational Site	Offenbach	Hessen	Germany	63069
26	GSK Investigational Site	Wiesbaden	Hessen	Germany	65199
27	GSK Investigational Site	Greifswald	Mecklenburg-Vorpommern	Germany	17487
28	GSK Investigational Site	Neubrandenburg	Mecklenburg-Vorpommern	Germany	17036
29	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern	Germany	18057
30	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern	Germany	18059
31	GSK Investigational Site	Stralsund	Mecklenburg-Vorpommern	Germany	18437
32	GSK Investigational Site	Waren	Mecklenburg-Vorpommern	Germany	17192
33	GSK Investigational Site	Goettingen	Niedersachsen	Germany	37075
34	GSK Investigational Site	Leer	Niedersachsen	Germany	26789
35	GSK Investigational Site	Stade	Niedersachsen	Germany	21680
36	GSK Investigational Site	Bielefeld	Nordrhein-Westfalen	Germany	33604
37	GSK Investigational Site	Bochum	Nordrhein-Westfalen	Germany	44791
38	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53111
39	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53113
40	GSK Investigational Site	Bonn	Nordrhein-Westfalen	Germany	53177
41	GSK Investigational Site	Coesfeld	Nordrhein-Westfalen	Germany	48653
42	GSK Investigational Site	Dorsten	Nordrhein-Westfalen	Germany	46282
43	GSK Investigational Site	Duisburg	Nordrhein-Westfalen	Germany	47166
44	GSK Investigational Site	Duisburg	Nordrhein-Westfalen	Germany	47228
45	GSK Investigational Site	Hamm	Nordrhein-Westfalen	Germany	59071
46	GSK Investigational Site	Hemer	Nordrhein-Westfalen	Germany	58675
47	GSK Investigational Site	Herne	Nordrhein-Westfalen	Germany	44625
48	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	50924
49	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	50931
50	GSK Investigational Site	Krefeld	Nordrhein-Westfalen	Germany	47798
51	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen	Germany	46145
52	GSK Investigational Site	Velbert	Nordrhein-Westfalen	Germany	42551
53	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen	Germany	42283
54	GSK Investigational Site	Koblenz	Rheinland-Pfalz	Germany	56073
55	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz	Germany	67063
56	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55131
57	GSK Investigational Site	Trier	Rheinland-Pfalz	Germany	54290
58	GSK Investigational Site	Halle/Saale	Sachsen-Anhalt	Germany	06114
59	GSK Investigational Site	Magdeburg	Sachsen-Anhalt	Germany	39120
60	GSK Investigational Site	Chemnitz	Sachsen	Germany	09113
61	GSK Investigational Site	Leipzig	Sachsen	Germany	04207
62	GSK Investigational Site	Plauen	Sachsen	Germany	08529
63	GSK Investigational Site	Borstel	Schleswig-Holstein	Germany	23845
64	GSK Investigational Site	Flensburg	Schleswig-Holstein	Germany	24939
65	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein	Germany	22927
66	GSK Investigational Site	Erfurt	Thueringen	Germany	99089
67	GSK Investigational Site	Jena	Thueringen	Germany	07747
68	GSK Investigational Site	Berlin		Germany	10117
69	GSK Investigational Site	Berlin		Germany	12200
70	GSK Investigational Site	Berlin		Germany	12559
71	GSK Investigational Site	Berlin		Germany	13125
72	GSK Investigational Site	Berlin		Germany	13353
73	GSK Investigational Site	Berlin		Germany	13585
74	GSK Investigational Site	Berlin		Germany	14089
75	GSK Investigational Site	Berlin		Germany	14109
76	GSK Investigational Site	Bremen		Germany	28325
77	GSK Investigational Site	Hamburg		Germany	20246
78	GSK Investigational Site	Hamburg		Germany	21075
79	GSK Investigational Site	Hamburg		Germany	22043