Last updated: 11/03/2018 07:43:08

Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

GSK study ID
104864-A/389
See study documents
Clinicaltrials.gov ID
NCT00043927
EudraCT ID
Not applicable
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, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients with Extensive Disease-Small Cell Lung Cancer.
Trial description: This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: topotecan/cisplatin
  • Drug: etoposide/cisplatin
    • Enrollment:
    760
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Eckardt JR, von Pawel J, Manikhas G, Papai Z, Tomova A, Tzekova V, et al. Comparable activity with oral topotecan/cisplatin (TC) and IV etoposide/cisplatin (PE) as treatment for chemotherapy-naive patients (pts) with extensive disease small cell lung cancer (ED-SCLC): Final results of a randomized Phase III trial (389). 41 Annu. Meet. Am. Soc. Clin. Oncol. 2005; Abs No 7003.
    Medical condition
    Small Cell Lung Cancer
    Product
    topotecan
    Collaborators
    None
    Study date(s)
    June 2001 to January 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    no
    • Written informed consent (patient's written understanding of and agreement to participate in this study).
    • Patients with confirmed extensive small cell lung cancer (SCLC).
    • Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
    • Any active infection.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Written informed consent (patient's written understanding of and agreement to participate in this study).
    • Patients with confirmed extensive small cell lung cancer (SCLC).
    • No prior chemotherapy within 5 years of the diagnosis of SCLC.
    • Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
    • At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
    • At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
    • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
    Exclusion criteria:
    • Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
    • Any active infection.
    • Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
    • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
    • Use of an investigational drug within 30 days before the first dose of study medication.
    • Women who are pregnant or lactating.
    • Patients of child-bearing potential who refuse to practice an adequate form of birth control.
    • Patients with clinical evidence of any stomach or intestinal (GI) condition.
    • Patients requiring treatment with the drug cyclosporin A.

    Trial location(s)

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    Fortaleza, N/A, Brazil, 60430-230
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    Salvador, N/A, Brazil, 41920-000
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    Sao Paulo, N/A, Brazil, 04023-062
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    Belo Horizonte, N/A, Brazil, 30140-083
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    Heidelberg, Baden-Wurttemberg, Germany, 69126
    Status
    Recruitment Complete
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    Location
    GSK Clinical Trials Call Center
    Ebensfeld, Bayern, Germany, 96250
    Status
    Recruitment Complete
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    Location
    GSK Clinical Trials Call Center
    Roma, N/A, Italy, 149
    Status
    Recruitment Complete
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    Location
    GSK Clinical Trials Call Center
    Sydney, NS, Canada, B1P 1P3
    Status
    Recruitment Complete
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    Location
    GSK Clinical Trials Call Center
    Liege, N/A, Belgium, 4000
    Status
    Recruitment Complete
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    Location
    GSK Clinical Trials Call Center
    Wangfujing, China, 100730
    Status
    Study Complete
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    Location
    GSK Clinical Trials Call Center
    Toronto, ON, Canada, M5G 2M9
    Status
    Recruitment Complete
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    Location
    GSK Clinical Trials Call Center
    Peterborough, ON, Canada, K9H 7B6
    Status
    Recruitment Complete
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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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-30-01

    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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