NCT00390364

Everolimus in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Previous Therapy

Phase II Study of Single Agent RAD001 in Patients With Colon Cancer and Activating Mutations in the PI3KCA Gene

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with advanced or metastatic colorectal cancer that did not respond to previous therapy.

Detailed description

OBJECTIVES: * Determine response rate, time to tumor progression, and survival of patients with advanced or metastatic refractory colorectal cancer and mutations in the PI3K gene treated with everolimus. * Determine the toxicity profile of this drug in these patients. * Measure the signaling pathways activated in these patients. * Determine the pharmacodynamic effects of this drug in these patients. OUTLINE: This is an open-label study. Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies and normal skin biopsies at baseline and after the first course of study treatment. Tumor tissue is examined for biological markers (e.g., epidermal growth factor receptor, ERK, Akt, p70s6k, p27, and Rb protein) by immunohistochemistry; apoptosis quantification by TUNEL assay; Ki-67 quantification and Ki-index; gene expression; and c-fos and p27 expression by reverse-transcriptase polymerase chain reaction. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	everolimus
PROCEDURE	antiangiogenesis therapy
PROCEDURE	biopsy
PROCEDURE	diagnostic procedure
PROCEDURE	gene expression analysis
PROCEDURE	immunohistochemistry staining method
PROCEDURE	laboratory biomarker analysis
PROCEDURE	mutation analysis
PROCEDURE	protein tyrosine kinase inhibitor therapy
PROCEDURE	reverse transcriptase-polymerase chain reaction

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-10-19
• Last updated: 2014-10-08
• Results posted: 2014-10-08

Locations

1 site across 1 country: United States