A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00478634
Last Updated: 2012-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2007-05-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A1: RAD001 + cetuximab + irinotecan
RAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v.
RAD001, Cetuximab, Irinotecan
B1 dose: RAD001 + cetuximab + irinotecan
RAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.
RAD001, Cetuximab, Irinotecan
Interventions
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RAD001, Cetuximab, Irinotecan
Eligibility Criteria
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Inclusion Criteria
* Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
* Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
* Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
* Patients with a WHO performance status of 0 or 1.
Exclusion Criteria
* Patients who are homozygous for the UGT1A1\*28 allele as determined by sequencing.
* Patients who have received previous irinotecan-based therapy.
* Prior treatment with an mTOR inhibitor.
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Comprehensive nBlood and Cancer Care
Bakersfield, California, United States
UCSD - Moores Cancer Center
La Jolla, California, United States
Comprehensive Cancer Care
Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
Northridge, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Gerogetown University Lombardi Cancer Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Oncology Specialists
Park Ridge, Illinois, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
UNC School of Medicine
Chapel Hill, North Carolina, United States
Oncology/Hematology Associates
Bethlehem, Pennsylvania, United States
Arlington Cancer Center
Arlington, Texas, United States
Countries
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Other Identifiers
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CRAD001C2242
Identifier Type: -
Identifier Source: org_study_id