Carboplatin and Etoposide With or Without Thalidomide in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer
NCT00061919 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 724
Last updated 2012-03-16
Summary
RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer.
Conditions
Interventions
- DRUG
-
Carboplatin, etoposide & thalidomide
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.
- DRUG
-
Carboplatin, etoposide & placebo
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.
Sponsors & Collaborators
-
University College, London
lead OTHER
Principal Investigators
-
Siow M. Lee, MD, PhD, FRCP · University College London Hospitals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-04-30
- Primary Completion
- 2007-02-28
- Completion
- 2007-07-31
Countries
- United Kingdom
Study Locations
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