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

Phase 1

Completed

• Conditions: Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal
• Interventions: Drug: RAD001, Cetuximab, Irinotecan

• Registration Number: NCT00478634
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will assess the safety of RAD001 when given together with cetuximab and irinotecan

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1: RAD001 + cetuximab + irinotecan	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.
B1 dose: RAD001 + cetuximab + irinotecan	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.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities	at end of cycle 2	each cycle was 21 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of RAD001, Irinotecan and SN-38
Progressions Free Survival
Overall Survival
Objective Response Rate

Trial Locations

Locations (16)

UCSD - Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Highlands Oncology Group; 🇺🇸 Fayetteville, Arkansas, United States

Cancer Care Associates Medical Group, Inc.; 🇺🇸 Redondo Beach, California, United States

Comprehensive nBlood and Cancer Care; 🇺🇸 Bakersfield, California, United States

North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center; 🇺🇸 Northridge, California, United States

Norwalk Hospital; 🇺🇸 Norwalk, Connecticut, United States

Gerogetown University Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Richmond University Medical Center; 🇺🇸 Staten Island, New York, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

Oncology Specialists; 🇺🇸 Park Ridge, Illinois, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

UNC School of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States

Arlington Cancer Center; 🇺🇸 Arlington, Texas, United States

Oncology/Hematology Associates; 🇺🇸 Bethlehem, Pennsylvania, United States

Comprehensive Cancer Care; 🇺🇸 Los Angeles, California, United States