Paclitaxel, Carboplatin, and Dimethylxanthenone Acetic Acid in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Carboplatin and Paclitaxel Plus ASA404 as First Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): A Phase II Trial|
- Progression-free survival rate [ Time Frame: at 24 weeks (6 months) ] [ Designated as safety issue: No ]
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.
- Adverse events by NCI CTCAE v3.0 [ Time Frame: until 30 days after trial therapy end ] [ Designated as safety issue: Yes ]
- Best objective response OR complete or partial response according to RECIST 1.1 [ Time Frame: whilst receiving the trial therapy ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Time from registration until death as a result of any cause. ] [ Designated as safety issue: No ]
- One-year survival rate [ Time Frame: at 1 year ] [ Designated as safety issue: No ]Patients alive one year after trial registration
|Study Start Date:||January 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Paclitaxel, Carboplatin, ASA404||
AUC 6 i.v. given after paclitaxel as the second treatment on day 1 of each 3-week cycle.
Other Name: ParaplatinDrug: paclitaxel
175 mg/m2 i.v. first treatment on day 1 of each 3-week cycle.
Other Name: Abraxane TaxolDrug: vadimezan
1800 mg/m2 i.v. following the administration of paclitaxel and carboplatin on day 1 of each 3-week cycle
Other Name: ASA404
- 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.
- 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.
|Basel, Switzerland, CH-4031|
|Saint Claraspital AG|
|Basel, Switzerland, CH-4016|
|Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni|
|Bellinzona, Switzerland, CH-6500|
|Bern, Switzerland, CH-3010|
|Biel, Switzerland, CH-2501|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Olten, Switzerland, CH-4600|
|Schaffhausen, Switzerland, CH-8200|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Thun, Switzerland, 3600|
|Winterthur, Switzerland, CH-8400|
|Zurich, Switzerland, CH-8032|
|Study Chair:||Martin Frueh, MD||Cantonal Hospital of St. Gallen|
|Study Chair:||Miklos Pless, MD||Kantonsspital Winterthur KSW|
|Study Chair:||Oliver Gautschi, MD||University Hospital Inselspital, Berne|