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

Completed · Phase 3

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00043927

Run by

GlaxoSmithKline

People needed

760

Starts

2001-04-01

Last updated by the study team

2013-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• GSK Clinical Trials Call Center — Vista, California, United States
• GSK Clinical Trials Call Center — Colorado Springs, Colorado, United States
• GSK Clinical Trials Call Center — Norwich, Connecticut, United States
• GSK Clinical Trials Call Center — Washington D.C., District of Columbia, United States
• GSK Clinical Trials Call Center — Gainesville, Florida, United States
• GSK Clinical Trials Call Center — Miami Shores, Florida, United States
• GSK Clinical Trials Call Center — Ocala, Florida, United States
• GSK Clinical Trials Call Center — Pensacola, Florida, United States
• GSK Clinical Trials Call Center — Tarpon Springs, Florida, United States
• GSK Clinical Trials Call Center — Atlanta, Georgia, United States
• GSK Clinical Trials Call Center — Atlanta, Georgia, United States
• GSK Clinical Trials Call Center — Atlanta, Georgia, United States
• GSK Clinical Trials Call Center — Atlanta, Georgia, United States
• GSK Clinical Trials Call Center — Augusta, Georgia, United States
• GSK Clinical Trials Call Center — Cumming, Georgia, United States
• GSK Clinical Trials Call Center — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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