Last updated: 11/03/2018 07:44:17

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

GSK study ID
104864-A/479
See study documents
Clinicaltrials.gov ID
NCT00320359
See results summary
EudraCT ID
2005-000675-18
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Median overall survival time of participants

Timeframe: Up to 1 year after randomization of the last participant

Secondary outcomes:

Percentage of participants with one year survival rate

Timeframe: Up to 1 year after randomization of the last participant

Median time of disease progression

Timeframe: Up to 1 year after randomization of the last participant

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

Timeframe: Up to 1 year after randomization of the last participant

Median time to response to chemotherapy

Timeframe: Up to 1 year after randomization of the last participant

Median response duration

Timeframe: Up to 1 year after randomization of the last participant

Percentage of participants with objective response

Timeframe: Up to 1 year after randomization of the last participant

Area under curve (AUC) of lung cancer symptom scale (LCSS) score over the course of treatment

Timeframe: Up to 18 weeks

Mean eastern cooperative oncology group (ECOG) score

Timeframe: Up to 18 weeks

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

Timeframe: Up to 1 year after randomization of the last participant (approximately 4.5 years).

Interventions:
  • Drug: Intravenous topotecan/cisplatin
  • Drug: Intravenous etoposide/cisplatin
    • Enrollment:
    700
    Primary completion date:
    2007-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lung Cancer, Small Cell
    Product
    topotecan
    Collaborators
    Not applicable
    Study date(s)
    August 2002 to February 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    No
    • Evaluable extensive small cell lung cancer, extensive disease.
    • Eastern Cooperative Oncology Group (ECOG) performance status < 2.
    • Extensive disease treatable with radiotherapy.
    • Past or current history of other malignant disease.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Grosshansdorf, Schleswig-Holstein, Germany, 22927
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Borstel, Schleswig-Holstein, Germany, 23845
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55131
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Karlsruhe, Baden-Wuerttemberg, Germany, 76137
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greifswald, Mecklenburg-Vorpommern, Germany, 17487
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Plauen, Sachsen, Germany, 08529
    Status
    Terminated/Withdrawn
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-28-02
    Actual study completion date
    2007-28-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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