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Completed Phase 1Phase 2 Interventional

Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

ClinicalTrials.gov ID: NCT00522665

Public ClinicalTrials.gov record NCT00522665. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 27, 2026, 8:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I / Randomized Phase II Study of Second Line Therapy With Irinotecan and Cetuximab With or Without RAD001, an Oral mTOR Inhibitor for Patients With Metastatic Colorectal Cancer: Hoosier Oncology Group GI05-102

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance.

Study identification

NCT ID
NCT00522665
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
41 participants

Conditions and interventions

Interventions

Drug · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2007
Primary completion
Apr 30, 2011
Completion
Jan 31, 2015
Last update posted
May 14, 2015

2007 – 2015

United States locations

U.S. sites
14
U.S. states
3
U.S. cities
10
Facility City State ZIP Site status
Northwestern University Feinberg School of Medicine Chicago Illinois 60611 —
Medical & Surgical Specialists, LLC Galesburg Illinois 61401 —
Cancer Care Center of Southern Indiana Bloomington Indiana 47403 —
Oncology Hematology Associates of SW Indiana Evansville Indiana 47714 —
IN Onc/Hem Associates Indianapolis Indiana 46202 —
Indiana University Simon Cancer Center Indianapolis Indiana 46202 —
St. Vincent Hospital & Health Centers Indianapolis Indiana 46206 —
Community Regional Cancer Center Indianapolis Indiana 46256 —
Arnett Cancer Care Lafayette Indiana 47904 —
Horizon Oncology Center Lafayette Indiana 47905 —
Monroe Medical Associates Munster Indiana 46321 —
Center for Cancer Care, Inc., P.C. New Albany Indiana 47150 —
Northern Indiana Cancer Research Consortium South Bend Indiana 46601 —
Siteman Cancer Center St Louis Missouri 63110 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00522665, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 14, 2015 · Synced Sep 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00522665 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →