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Lung Cancer, Small CellPhase 3NCT00320359

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

A Phase 3 study testing Intravenous topotecan/cisplatin and Intravenous etoposide/cisplatin in people with Lung Cancer, Small Cell, run by GlaxoSmithKline at 79 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer, Small Cell
What is being tested?
Intravenous topotecan/cisplatin and Intravenous etoposide/cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
79 sitesin 2 countries
Study dates
Aug 2002to Feb 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

79 sites in 2 countries.

79 sites in 2 countries

Germany75 sites

  • GSK Investigational Site

    Bayreuth, Bavaria, 95445

  • GSK Investigational Site

    Berlin, State of Berlin, 10117

  • GSK Investigational Site

    Berlin, State of Berlin, 12200

  • GSK Investigational Site

    Berlin, State of Berlin, 12559

  • GSK Investigational Site

    Berlin, State of Berlin, 13125

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Berlin, State of Berlin, 13585

  • GSK Investigational Site

    Berlin, State of Berlin, 14089

  • GSK Investigational Site

    Berlin, State of Berlin, 14109

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33604

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44791

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53111

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53113

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53177

  • GSK Investigational Site

    Borstel, Schleswig-Holstein, 23845

  • GSK Investigational Site

    Bremen, Free Hanseatic City of Bremen, 28325

  • GSK Investigational Site

    Chemnitz, Saxony, 09113

  • GSK Investigational Site

    Coesfeld, North Rhine-Westphalia, 48653

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50924

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50931

  • GSK Investigational Site

    Cottbus, Brandenburg, 03048

  • GSK Investigational Site

    Dorsten, North Rhine-Westphalia, 46282

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47166

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47228

  • GSK Investigational Site

    Erfurt, Thuringia, 99089

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24939

  • GSK Investigational Site

    Frankfurt (Oder), Brandenburg, 15236

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60431

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 65929

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Giessen, Hesse, 35392

  • GSK Investigational Site

    Göttingen, Lower Saxony, 37075

  • GSK Investigational Site

    Greifenstein, Hesse, 35753

  • GSK Investigational Site

    Greifswald, Mecklenburg-Vorpommern, 17487

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06114

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 21075

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22043

  • GSK Investigational Site

    Hamm, North Rhine-Westphalia, 59071

  • GSK Investigational Site

    Hemer, North Rhine-Westphalia, 58675

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44625

  • GSK Investigational Site

    Jena, Thuringia, 07747

  • GSK Investigational Site

    Karlsruhe, Baden-Wurttemberg, 76137

  • GSK Investigational Site

    Kassel, Hesse, 34125

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56073

  • GSK Investigational Site

    Krefeld, North Rhine-Westphalia, 47798

  • GSK Investigational Site

    Leer, Lower Saxony, 26789

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Limburg an der Lahn, Hesse, 65549

  • GSK Investigational Site

    Löwenstein, Baden-Wurttemberg, 74245

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39120

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Marburg, Hesse, 35043

  • GSK Investigational Site

    Munich, Bavaria, 80336

  • GSK Investigational Site

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

  • GSK Investigational Site

    Nuremberg, Bavaria, 90340

  • GSK Investigational Site

    Oberhausen, North Rhine-Westphalia, 46145

  • GSK Investigational Site

    Offenbach, Hesse, 63069

  • GSK Investigational Site

    Passau, Bavaria, 94032

  • GSK Investigational Site

    Plauen, Saxony, 08529

  • GSK Investigational Site

    Regensburg, Bavaria, 93049

  • GSK Investigational Site

    Rosenheim, Bavaria, 83022

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18057

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18059

  • GSK Investigational Site

    Stade, Lower Saxony, 21680

  • GSK Investigational Site

    Stralsund, Mecklenburg-Vorpommern, 18437

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

  • GSK Investigational Site

    Wangen, Baden-Wurttemberg, 88239

  • GSK Investigational Site

    Waren, Mecklenburg-Vorpommern, 17192

  • GSK Investigational Site

    Wiesbaden, Hesse, 65199

  • GSK Investigational Site

    Wuppertal, North Rhine-Westphalia, 42283

Other trials in Germany

Austria4 sites

  • GSK Investigational Site

    Bludesch, A-6719

  • GSK Investigational Site

    Klagenfurt, A-9020

  • GSK Investigational Site

    Linz, A-4020

  • GSK Investigational Site

    Vienna, A-1140

Other trials in Austria

About this study

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

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

Being tested
Intravenous topotecan/cisplatin, Intravenous etoposide/cisplatin
Keywords
First-line Cisplatin, Small Cell Lung Cancer, topotecan, etoposide, Extensive Disease
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous topotecan/cisplatinDrug

    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.

  • Intravenous etoposide/cisplatinDrug

    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.

Study groups in NCT00320359
Study groupRoleWhat they receive
Arm AActive comparatorCisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3
Receives: Drug: Intravenous etoposide/cisplatin
Arm BExperimentalTopotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
Receives: Drug: Intravenous topotecan/cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median overall survival time of participants

    Measured: Up to 1 year after randomization of the last patient

Secondary outcomes (20)

  1. Number of participants with one year survival rate of the participants

    Measured: Up to 1 year after randomization of the last patient

  2. Median time of disease progression

    Measured: up to 1 year after randomization of the last patient

  3. Median time to event (progressive disease or death) of participants

    Measured: Up to 1 year after randomization of the last patient

  4. Median time to response to chemotherapy

    Measured: Up to 1 year after randomization of the last patient

  5. Median response duration

    Measured: Up to 1 year after randomization of the last patient

  6. Number of participants with objective response

    Measured: Up to 1 year after randomization of the last patient

  7. Mean lung cancer symptom score (LCSS)

    Measured: Up to 18 weeks

  8. Mean eastern cooperative oncology group (ECOG) score

    Measured: Up to 18 weeks

  9. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Measured: Up to 1 year after randomization of the last patient

  10. Mean change from Baseline in hemoglobin value

    Measured: Baseline and up to 18 weeks

  11. Mean change from Baseline in leukocytes, neutrophils and platelets count

    Measured: Baseline and up to 18 weeks

  12. Mean change from Baseline in red blood cells (RBCs)

    Measured: Baseline and up to 18 weeks

  13. Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH)

    Measured: Baseline and up to 18 weeks

  14. Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea

    Measured: Baseline and up to 18 weeks

  15. Mean change from Baseline in Creatinine and Total bilirubin

    Measured: Baseline and up to 18 weeks

  16. Mean change from Baseline in Creatinine clearance

  17. Mean change from Baseline in total protein

    Measured: Baseline and up to 18 weeks

  18. Number of participants with abnormal urinalysis results

  19. Mean change from Baseline in weight

    Measured: Baseline and up to 18 weeks

  20. Mean change from Baseline in Body surface area

    Measured: Baseline and up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2006 (estimated)
  2. Study startAug 2002
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00320359
Sponsor's protocol ID
104864-A/479
Status last verified
Feb 2017
First submitted
1 May 2006
Last updated
1 Mar 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous topotecan/cisplatin and Intravenous etoposide/cisplatin in people with Lung Cancer, Small Cell, run by GlaxoSmithKline at 79 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median overall survival time of participants (time frame: Up to 1 year after randomization of the last patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00320359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.

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