Lung Cancer Clinical Trial
Official title:
Carboplatin and Paclitaxel Plus ASA404 as First Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): A Phase II Trial
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Dimethylxanthenone acetic acid may stop the growth of small cell lung cancer by
blocking blood flow to the tumor. Giving paclitaxel and carboplatin together with
dimethylxanthenone acetic acid may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and
carboplatin together with dimethylxanthenone acetic acid and to see how well they work in
treating patients with extensive-stage small cell lung cancer.
OBJECTIVES:
Primary
- To assess the 24-week (6 months) progression-free survival of patients with extensive
stage small cell lung cancer treated with paclitaxel, carboplatin, and
dimethylxanthenone acetic acid.
Secondary
- To assess efficacy and safety of this regimen in these patients.
- To evaluate predictive molecular markers for gene expression analyses, serum
proteomics, and pharmacogenomics. (exploratory)
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and
dimethylxanthenone acetic acid IV over 20 minutes on day 1. Treatment repeats every 21 days
for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples may be collected periodically for predictive molecular markers for
gene expression analysis, plasma proteomics, and pharmacogenomics.
After completion of study treatment, patients are followed every 6 months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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