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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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00478634
Collaborator
(none)
19
Enrollment
16
Locations
2
Arms
28.1
Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: RAD001, Cetuximab, Irinotecan
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2007
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: RAD001, Cetuximab, Irinotecan
Experimental: 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.

Drug: RAD001, Cetuximab, Irinotecan

Outcome Measures

Primary Outcome Measures

  1. Dose Limiting Toxicities [at end of cycle 2]

    each cycle was 21 days

Secondary Outcome Measures

  1. Pharmacokinetics of RAD001, Irinotecan and SN-38 []

  2. Progressions Free Survival []

  3. Overall Survival []

  4. Objective Response Rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Highlands Oncology Group Fayetteville Arkansas United States 72701
2 Comprehensive nBlood and Cancer Care Bakersfield California United States 93309
3 UCSD - Moores Cancer Center La Jolla California United States 92037
4 Comprehensive Cancer Care Los Angeles California United States 90095
5 North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center Northridge California United States 91325
6 Cancer Care Associates Medical Group, Inc. Redondo Beach California United States 90277
7 Norwalk Hospital Norwalk Connecticut United States 06850
8 Gerogetown University Lombardi Cancer Center Washington District of Columbia United States 20057
9 H. Lee Moffitt Cancer Center Tampa Florida United States 33612
10 Oncology Specialists Park Ridge Illinois United States 60068
11 Nevada Cancer Institute Las Vegas Nevada United States 89135
12 Roswell Park Cancer Institute Buffalo New York United States 14263
13 Richmond University Medical Center Staten Island New York United States 10310
14 UNC School of Medicine Chapel Hill North Carolina United States 27599
15 Oncology/Hematology Associates Bethlehem Pennsylvania United States 18017
16 Arlington Cancer Center Arlington Texas United States 76012

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00478634
Other Study ID Numbers:
  • CRAD001C2242
First Posted:
May 25, 2007
Last Update Posted:
Nov 2, 2012
Last Verified:
Nov 1, 2012
Keywords provided by Novartis Pharmaceuticals
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
Additional relevant MeSH terms:
Colorectal Neoplasms
Irinotecan
Cetuximab
Everolimus

Study Results

No Results Posted as of Nov 2, 2012