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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
Not Enrolling
Both
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

Thank you

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 InstituteBuffalo, New York  14263
Arlington Cancer CenterArlington, Texas  76012
Highlands Oncology GroupSpringdale, Arkansas  72764
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Cancer Care Associates Medical Group, Inc.Torrance, California  90505
UNC School of MedicineChapel Hill, North Carolina  27599
Nevada Cancer InstituteLas Vegas, Nevada  89135
Norwalk HospitalNorwalk, Connecticut  06856
Oncology SpecialistsPark Ridge, Illinois  60068
Richmond University Medical CenterStaten Island, New York  10310-1699
Comprehensive Cancer CarePalm Springs, California  92262
Comprehensive nBlood and Cancer CareBakersfield, California  93309
UCSD - Moores Cancer CenterLa Jolla, California  92037
North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer CenterNorthridge, California  91325
Gerogetown University Lombardi Cancer CenterWashington, District of Columbia  20057
Oncology/Hematology AssociatesBethlehem, Pennsylvania  18017