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
Phase 1
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Both
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Trial Information
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose Limiting Toxicities
Outcome Description:
each cycle was 21 days
Outcome Time Frame:
at end of cycle 2
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001C2242
NCT ID:
NCT00478634
Start Date:
May 2007
Completion Date:
September 2009
Related Keywords:
- Colorectal Cancer
- Colorectal Carcinoma
- Colorectal Tumors
- Neoplasms, Colorectal
- Colorectal Cancer
- Colorectal Carcinoma
- Colorectal Tumors
- Neoplasms, Colorectal
- Neoplasms
- Carcinoma
- Colorectal Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Arlington Cancer Center | Arlington, Texas 76012 |
| Highlands Oncology Group | Springdale, Arkansas 72764 |
| H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| Cancer Care Associates Medical Group, Inc. | Torrance, California 90505 |
| UNC School of Medicine | Chapel Hill, North Carolina 27599 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Norwalk Hospital | Norwalk, Connecticut 06856 |
| Oncology Specialists | Park Ridge, Illinois 60068 |
| Richmond University Medical Center | Staten Island, New York 10310-1699 |
| Comprehensive Cancer Care | Palm Springs, California 92262 |
| Comprehensive nBlood and Cancer Care | Bakersfield, California 93309 |
| UCSD - Moores Cancer Center | La Jolla, California 92037 |
| North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center | Northridge, California 91325 |
| Gerogetown University Lombardi Cancer Center | Washington, District of Columbia 20057 |
| Oncology/Hematology Associates | Bethlehem, Pennsylvania 18017 |
