Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00406276
• Study type: Interventional
• Source: Emory University
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 2006
• Completion date: February 2013