Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer|
- Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started.
- Time to Progression:Time Period (in Months) From Study Entry Until Disease Progression, Death, or Last Date of Contact. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Period from study entry until disease progression, death, or last date of contact.
Progressive Disease: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
|Study Start Date:||November 2006|
|Study Completion Date:||February 2013|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
RAD001 in combination with Docetaxel.
RAD001 will be given at a dose of 5mg/day in combination with docetaxelDrug: Docetaxel
In combination with RAD001
This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus published Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.
New agents and regimens are urgently needed for lung cancer treatment. With the development of novel agents and small molecules designed to curtail the aggressive aspects of this disease, some progress has been realized. However, much more effort and insight will be required for further real gains to be made. We propose that studying the mTOR axis, known to be abnormal in non-small cell lung cancer (NSCLC), and translating that knowledge into therapeutic adjustments can lead to meaningful advances in lung cancer treatment.
Approximately 58 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406276
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Suresh Ramalingam, MD||Emory University Winship Cancer Institute|