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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

Primary Purpose

Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RAD001, Cetuximab, Irinotecan
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Highlands Oncology Group
  • Comprehensive nBlood and Cancer Care
  • UCSD - Moores Cancer Center
  • Comprehensive Cancer Care
  • North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
  • Cancer Care Associates Medical Group, Inc.
  • Norwalk Hospital
  • Gerogetown University Lombardi Cancer Center
  • H. Lee Moffitt Cancer Center
  • Oncology Specialists
  • Nevada Cancer Institute
  • Roswell Park Cancer Institute
  • Richmond University Medical Center
  • UNC School of Medicine
  • Oncology/Hematology Associates
  • Arlington Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A1: RAD001 + cetuximab + irinotecan

B1 dose: RAD001 + cetuximab + irinotecan

Arm Description

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 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicities
each cycle was 21 days

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2007
Last Updated
November 1, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00478634
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Keywords
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1: RAD001 + cetuximab + irinotecan
Arm Type
Experimental
Arm Description
RAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v.
Arm Title
B1 dose: RAD001 + cetuximab + irinotecan
Arm Type
Experimental
Arm Description
RAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.
Intervention Type
Drug
Intervention Name(s)
RAD001, Cetuximab, Irinotecan
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities
Description
each cycle was 21 days
Time Frame
at end of cycle 2
Secondary Outcome Measure Information:
Title
Pharmacokinetics of RAD001, Irinotecan and SN-38
Title
Progressions Free Survival
Title
Overall Survival
Title
Objective Response Rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States
Facility Name
Comprehensive nBlood and Cancer Care
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
UCSD - Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Comprehensive Cancer Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Cancer Care Associates Medical Group, Inc.
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Gerogetown University Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Oncology Specialists
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
UNC School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Oncology/Hematology Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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