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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00043927 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: topotecan/cisplatin Drug: etoposide/cisplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 178 Study Locations| Study Director: | GSK Clinical Trial, MD | GlaxoSmithKline |
More Information
| Study ID Numbers: | 104864-A/389 |
| Study First Received: | August 14, 2002 |
| Last Updated: | March 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00043927 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Chemotherapy-naive Small Cell Lung Cancer SCLC Extensive disease |
ED topotecan Hycamtin oral |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Etoposide Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Enzyme Inhibitors Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases Adenocarcinoma Topotecan Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |