Paclitaxel, Carboplatin, and Dimethylxanthenone Acetic Acid in Treating Patients With Extensive-Stage Small Cell Lung Cancer
- Registration Number
- NCT01057342
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Paclitaxel, Carboplatin, ASA404 paclitaxel - Paclitaxel, Carboplatin, ASA404 carboplatin - Paclitaxel, Carboplatin, ASA404 vadimezan -
- Primary Outcome Measures
Name Time Method Progression-free survival rate at 24 weeks (6 months) The status of progression free survival at 24 weeks (+/- 2 weeks) from trial registration will be assessed. A PFS event is defined as (whichever occurs first):
* Relapse or progression assessed according to the RECIST 1.1 criteria (Appendix 1)
* Death of any cause.
- Secondary Outcome Measures
Name Time Method Adverse events by NCI CTCAE v3.0 until 30 days after trial therapy end Best objective response OR complete or partial response according to RECIST 1.1 whilst receiving the trial therapy Time to progression Defined as the time from registration until documented Small-cell Lung Cancer (SCLC) progression or death as a result of SCLC. Overall survival Time from registration until death as a result of any cause. One-year survival rate at 1 year Patients alive one year after trial registration
Trial Locations
- Locations (12)
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Spitalzentrum Biel
🇨ðŸ‡Biel, Switzerland
Saint Claraspital AG
🇨ðŸ‡Basel, Switzerland
Universitaetsspital-Basel
🇨ðŸ‡Basel, Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Kantonsspital Olten
🇨ðŸ‡Olten, Switzerland
Onkologie Schaffhausen
🇨ðŸ‡Schaffhausen, Switzerland
Regionalspital
🇨ðŸ‡Thun, Switzerland
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
Kantonsspital Winterthur
🇨ðŸ‡Winterthur, Switzerland
Klinik Hirslanden
🇨ðŸ‡Zurich, Switzerland