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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00043927
Recruitment Status : Completed
First Posted : August 16, 2002
Last Update Posted : August 21, 2013
Information provided by:

August 14, 2002
August 16, 2002
August 21, 2013
April 2001
January 2004   (Final data collection date for primary outcome measure)
Overall Survival
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Complete list of historical versions of study NCT00043927 on Archive Site
response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients
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Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
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.
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: topotecan/cisplatin
  • Drug: etoposide/cisplatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Costa Rica,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Honduras,   Hungary,   Italy,   Jamaica,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Norway,   Panama,   Poland,   Puerto Rico,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   United Kingdom,   United States
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Study Director: GSK Clinical Trial, MD GlaxoSmithKline
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP