Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer
The objective of this phase I study is to determine the maximum tolerated dose (MTD) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer|
- To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- To evaluate the objective response rate by RECIST 1.1 criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: taxol plus everolimus||
Drug: taxol plus everolimus
taxol 175mg/m2 every 3 weeks plus everolimus every day. The dose of everolimus will be started from 2.5mg per day, and increasing to 5mg per day and to 10mg per day.
Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancer, and more than half of these patients are diagnosed with extensive-stage disease (ED). SCLC is a particularly aggressive form of lung cancer with a tendency for rapid tumor growth, early dissemination and high frequency of the metastasis In this study, we evaluate the MTD of everolimus combined with paclitaxel combination chemotherapy in SCLC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079481
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Keunchil Park, M.D., Ph.D||Samsung Medical Center|