Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390364
Status:
TERMINATED
Last Update Posted:
2014-10-08
First Post:
2006-10-18
Brief Title:
Everolimus in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Previous Therapy
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Study of Single Agent RAD001 in Patients With Colon Cancer and Activating Mutations in the PI3KCA Gene
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn due to low accrual
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NOVARTIS-JHOC-J05107 | None | None | None |
| JHOC-J05107 | None | None | None |