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

NCT00522665 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-05-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Irinotecan

Irinotecan 125 mg/m2 IV days 1 and 8

BIOLOGICAL

Cetuximab

Cetuximab 250mg/m2 IV days 1, 8 and 15

BIOLOGICAL

RAD001

Patients on Arm A will crossover and receive RAD001 at disease progression

Sponsors & Collaborators

Principal Investigators

  • Gabriela Chiorean, M.D. · Hoosier Oncology Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-05-31
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522665 on ClinicalTrials.gov