Ignite Creation Date:
2024-05-05 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00754494
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2008-09-17
Brief Title:
Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIa Randomized Double-Blind Trial of Erlotinib in Inhibiting EGF Receptor Signaling in Aberrant Crypt Foci of the Colon
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial is studying how well erlotinib hydrochloride works in treating patients with stage I-III colorectal cancer or adenoma Erlotinib hydrochloride 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 Erlotinib hydrochloride may also stop tumors from growing or coming back
Detailed Description:
PRIMARY OBJECTIVES
I To test the hypothesis that erlotinib erlotinib hydrochloride doses as low as 25 mg will decrease aberrant crypt foci ACF phosphorylated extracellular signal-regulated kinases pERK levels from baseline pre to post erlotinib treatment
SECONDARY OBJECTIVES
I To test the hypothesis that additional epidermal growth factor EGF inducible biomarkers will decrease from baseline pre to post treatment with erlotinib 25 mg 50 mg or 100 mg orally PO once daily QD therapy
II To determine the mean decrease from baseline of the ACF normal mucosa pERK ratio pre and post 8-30 days of erlotinib
III To determine erlotinib concentration in plasma and colorectal tissue at 25 mg 50 mg and 100 mg doses after 8-30 days of therapy
IV To determine the incidence of rash diarrhea and other side effects of low dose erlotinib
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD
ARM II Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD
ARM III Patients receive 25 mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD
In all arms treatment continues for 8-30 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 4 to 9 weeks
I To test the hypothesis that erlotinib erlotinib hydrochloride doses as low as 25 mg will decrease aberrant crypt foci ACF phosphorylated extracellular signal-regulated kinases pERK levels from baseline pre to post erlotinib treatment
SECONDARY OBJECTIVES
I To test the hypothesis that additional epidermal growth factor EGF inducible biomarkers will decrease from baseline pre to post treatment with erlotinib 25 mg 50 mg or 100 mg orally PO once daily QD therapy
II To determine the mean decrease from baseline of the ACF normal mucosa pERK ratio pre and post 8-30 days of erlotinib
III To determine erlotinib concentration in plasma and colorectal tissue at 25 mg 50 mg and 100 mg doses after 8-30 days of therapy
IV To determine the incidence of rash diarrhea and other side effects of low dose erlotinib
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD
ARM II Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD
ARM III Patients receive 25 mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD
In all arms treatment continues for 8-30 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 4 to 9 weeks
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 |
|---|---|---|---|
| UCI06-8-01 | None | None | None |
| N01CN35160 | NIH | None | None |
| CDR0000614277 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CN35160 |