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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
AUC 6 i.v. given after paclitaxel as the second treatment on day 1 of each 3-week cycle.
175 mg/m2 i.v. first treatment on day 1 of each 3-week cycle.
1800 mg/m2 i.v. following the administration of paclitaxel and carboplatin on day 1 of each 3-week cycle
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
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland
Onkologie Schaffhausen
Schaffhausen, Switzerland
Regionalspital
Thun, Switzerland
...and 2 more locations
Progression-free survival rate
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.
Time frame: at 24 weeks (6 months)
Adverse events by NCI CTCAE v3.0
Time frame: until 30 days after trial therapy end
Best objective response OR complete or partial response according to RECIST 1.1
Time frame: whilst receiving the trial therapy
Time to progression
Time frame: Defined as the time from registration until documented Small-cell Lung Cancer (SCLC) progression or death as a result of SCLC.
Overall survival
Time frame: Time from registration until death as a result of any cause.
One-year survival rate
Patients alive one year after trial registration
Time frame: at 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.