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Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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.

NCT00043927•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

Locations (176)

GSK Clinical Trials Call Center

Hoover, Alabama, United States

GSK Clinical Trials Call Center

Chula Vista, California, United States

GSK Clinical Trials Call Center

Fountain Valley, California, United States

GSK Clinical Trials Call Center

Greenbrae, California, United States

GSK Clinical Trials Call Center

Poway, California, United States

GSK Clinical Trials Call Center

Rancho Mirage, California, United States

GSK Clinical Trials Call Center

Sacramento, California, United States

GSK Clinical Trials Call Center

San Diego, California, United States

GSK Clinical Trials Call Center

San Diego, California, United States

GSK Clinical Trials Call Center

Soquel, California, United States

Key Dates

Start Date

April 1, 2001

Primary Completion Date

January 1, 2004

Last Updated

August 21, 2013

Enrollment

760

Estimated participants

Conditions

Small Cell Lung Cancer

Interventions

topotecan/cisplatin

DRUG

etoposide/cisplatin

DRUG

Sponsors

Lead Sponsor

GlaxoSmithKline

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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