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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00478634
First received: May 24, 2007
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
 Drug: RAD001, Cetuximab, Irinotecan
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Dose Limiting Toxicities [ Time Frame: at end of cycle 2 ] [ Designated as safety issue: Yes ]
    each cycle was 21 days


Secondary Outcome Measures:
  • Pharmacokinetics of RAD001, Irinotecan and SN-38 [ Designated as safety issue: No ]
  • Progressions Free Survival [ Designated as safety issue: No ]
  • Overall Survival [ Designated as safety issue: No ]
  • Objective Response Rate [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: May 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478634

Locations
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72701
United States, California
Comprehensive nBlood and Cancer Care
Bakersfield, California, United States, 93309
UCSD - Moores Cancer Center
La Jolla, California, United States, 92037
Comprehensive Cancer Care
Los Angeles, California, United States, 90095
North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
Northridge, California, United States, 91325
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
United States, District of Columbia
Gerogetown University Lombardi Cancer Center
Washington, District of Columbia, United States, 20057
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Oncology Specialists
Park Ridge, Illinois, United States, 60068
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Richmond University Medical Center
Staten Island, New York, United States, 10310
United States, North Carolina
UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Oncology/Hematology Associates
Bethlehem, Pennsylvania, United States, 18017
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00478634     History of Changes
Other Study ID Numbers: CRAD001C2242
Study First Received: May 24, 2007
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Sirolimus
 Everolimus
Irinotecan
Bevacizumab
Cetuximab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013