At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
erlotinib hydrochloride +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa Randomized, Double-Blind Trial of Erlotinib in Inhibiting EGF Receptor Signaling in Aberrant Crypt Foci of the Colon
In Brief
A Phase 2 clinical trial evaluating erlotinib hydrochloride, placebo, and 1 other intervention for Adenomatous Polyp and 16 related conditions. Completed, enrolled 45 participants across 3 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenomatous Polyp, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage I Colon Cancer, Stage I Rectal Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedSep 2008
Primary CompletionOct 2012
Study CompletionSep 2013
TodayJul 2026
First PostedSep 18, 2008
Enrollment StartJul 1, 2008
Primary CompletionOct 1, 2012
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.8 years ago
Interventions
erlotinib hydrochloridedrug
Given PO
placeboother
Given PO
laboratory biomarker analysisother
Correlative studies