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Brief Title: Paclitaxel, Carboplatin, and Dimethylxanthenone Acetic Acid in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official Title: Carboplatin and Paclitaxel Plus ASA404 as First Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): A Phase II Trial
Study ID: NCT01057342
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Saint Claraspital AG, Basel, , Switzerland
Universitaetsspital-Basel, Basel, , Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Spitalzentrum Biel, Biel, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital Olten, Olten, , Switzerland
Onkologie Schaffhausen, Schaffhausen, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Regionalspital, Thun, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Klinik Hirslanden, Zurich, , Switzerland
Name: Martin Frueh, MD
Affiliation: Cantonal Hospital of St. Gallen
Role: STUDY_CHAIR
Name: Miklos Pless, MD
Affiliation: Kantonsspital Winterthur KSW
Role: STUDY_CHAIR
Name: Oliver Gautschi, MD
Affiliation: Insel Gruppe AG, University Hospital Bern
Role: STUDY_CHAIR