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Topotecan Plus Cisplatin Vers...

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

NCT ID: NCT00320359

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2007-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Lung Cancer, Small Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

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

Group Type ACTIVE_COMPARATOR

Intravenous etoposide/cisplatin

Intervention Type 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 B

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

Group Type EXPERIMENTAL

Intravenous topotecan/cisplatin

Intervention Type 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.

Interventions

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Intravenous topotecan/cisplatin

Intervention Type DRUG

Intravenous etoposide/cisplatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Coesfeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Dorsten, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Duisburg, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Duisburg, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Hamm, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Hemer, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Herne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Krefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Oberhausen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Velbert, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Wuppertal, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Koblenz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Chemnitz, Saxony, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Plauen, Saxony, Germany

Site Status

GSK Investigational Site

Halle, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Borstel, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status