NCT01057342

Paclitaxel, Carboplatin, and Dimethylxanthenone Acetic Acid in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Carboplatin and Paclitaxel Plus ASA404 as First Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): A Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	AUC 6 i.v. given after paclitaxel as the second treatment on day 1 of each 3-week cycle.
DRUG	paclitaxel	175 mg/m2 i.v. first treatment on day 1 of each 3-week cycle.
DRUG	vadimezan	1800 mg/m2 i.v. following the administration of paclitaxel and carboplatin on day 1 of each 3-week cycle

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-05-01
• Completion: 2012-07-01
• First posted: 2010-01-27
• Last updated: 2013-04-10

Locations

12 sites across 1 country: Switzerland