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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00478634
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
May 31, 2007
Status verified
Nov 2012
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Dose Limiting Toxicities [ Time Frame: at end of cycle 2 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72701-
Comprehensive nBlood and Cancer CareBakersfieldCalifornia93309-
UCSD - Moores Cancer CenterLa JollaCalifornia92037-
Comprehensive Cancer CareLos AngelesCalifornia90095-
North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer CenterNorthridgeCalifornia91325-
Cancer Care Associates Medical Group, Inc.Redondo BeachCalifornia90277-
Norwalk HospitalNorwalkConnecticut06850-
Gerogetown University Lombardi Cancer CenterWashington D.C.District of Columbia20057-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Oncology SpecialistsPark RidgeIllinois60068-
Nevada Cancer InstituteLas VegasNevada89135-
Roswell Park Cancer InstituteBuffaloNew York14263-
Richmond University Medical CenterStaten IslandNew York10310-
UNC School of MedicineChapel HillNorth Carolina27599-
Oncology/Hematology AssociatesBethlehemPennsylvania18017-
Arlington Cancer CenterArlingtonTexas76012-

Find similar trials in Fayetteville, AR

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Highlands Oncology Group· Fayetteville, ARComprehensive nBlood and Cancer Care· Bakersfield, CAUCSD - Moores Cancer Center· La Jolla, CAComprehensive Cancer Care· Los Angeles, CANorth Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center· Northridge, CACancer Care Associates Medical Group, Inc.· Redondo Beach, CA

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