Clinical trial NCT00478634: 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
Official title: An Open-label, Multicenter Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab (if Given as Part of Local Standard Practice) in Patient With Metastatic Colorectal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
Keywords: Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years old and ≤ 65 years old.
* 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 with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
* 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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Dose Limiting Toxicities
timeFrame: at end of cycle 2
Secondary outcomes:
measure: Pharmacokinetics of RAD001, Irinotecan and SN-38
measure: Progressions Free Survival
measure: Overall Survival
measure: Objective Response Rate
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive nBlood and Cancer Care
state: California
city: La Jolla
country: United States
facility: UCSD - Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Comprehensive Cancer Care
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Washington
country: United States
facility: Gerogetown University Lombardi Cancer Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists
state: Illinois
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine
state: North Carolina
city: Bethlehem
country: United States
facility: Oncology/Hematology Associates
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: