A randomized phase II study of pemetrexed or RAD001 as second-line treatment of advanced non-small-cell lung cancer in elderly patients: treatment rationale and protocol dynamics

Clin Lung Cancer. 2007 Nov;8(9):568-71. doi: 10.3816/CLC.2007.n.045.

Abstract

In the current clinical trial summary, we present a randomized phase II trial of pemetrexed or RAD001 as second-line treatment of elderly patients with advanced non-small-cell lung cancer. The molecular and clinical rationale is reviewed. The primary endpoint is progression-free survival, and secondary endpoints include objective tumor response rates, disease control rates, safety, tolerability, and overall survival. Based on the statistical design, the investigators plan to enroll 92 elderly patients, 46 per arm.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antimetabolites, Antineoplastic / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology*
  • Carcinoma, Non-Small-Cell Lung / physiopathology
  • Disease-Free Survival
  • Everolimus
  • Female
  • Glutamates / administration & dosage
  • Glutamates / adverse effects
  • Guanine / administration & dosage
  • Guanine / adverse effects
  • Guanine / analogs & derivatives
  • Humans
  • Immunosuppressive Agents
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology*
  • Lung Neoplasms / physiopathology
  • Male
  • Neoplasm Staging
  • Pemetrexed
  • Sirolimus / administration & dosage
  • Sirolimus / adverse effects
  • Sirolimus / analogs & derivatives*

Substances

  • Antimetabolites, Antineoplastic
  • Glutamates
  • Immunosuppressive Agents
  • Pemetrexed
  • Guanine
  • Everolimus
  • Sirolimus