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Spots Global Cancer Trial Database for Paclitaxel, Carboplatin, and Dimethylxanthenone Acetic Acid in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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Trial Identification

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

Conditions

Lung Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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