Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Hoosier Cancer Research Network
Study ID
NCT00522665
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan 125 mg/m2 IV days 1 and 8
  • Cetuximab — BIOLOGICAL
    Cetuximab 250mg/m2 IV days 1, 8 and 15
  • RAD001 — BIOLOGICAL
    Patients on Arm A will crossover and receive RAD001 at disease progression

Study Details

The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance.

Key Dates

Start date
Aug 31, 2007
Status verified
May 2015
Primary completion
May 31, 2011
Completion
Feb 28, 2015

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Irinotecan + Cetuximab +/- RAD001
  • Active Comparator: Arm B: Ironotecan + Cetuximab

Primary Outcome Measure

To determine the MTD of RAD001 in combination with irinotecan and cetuximab as second line therapy in patients with metastatic colorectal cancer [ Time Frame: Phase I ]

Locations (14)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Medical & Surgical Specialists, LLCGalesburgIllinois61401-
Cancer Care Center of Southern IndianaBloomingtonIndiana47403-
Oncology Hematology Associates of SW IndianaEvansvilleIndiana47714-
Community Regional Cancer CenterIndianapolisIndiana46256-
IN Onc/Hem AssociatesIndianapolisIndiana46202-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
St. Vincent Hospital & Health CentersIndianapolisIndiana46206-
Arnett Cancer CareLafayetteIndiana47904-
Horizon Oncology CenterLafayetteIndiana47905-
Monroe Medical AssociatesMunsterIndiana46321-
Center for Cancer Care, Inc., P.C.New AlbanyIndiana47150-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
Siteman Cancer CenterSt LouisMissouri63110-

Find similar trials in Chicago, IL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Northwestern University Feinberg School of Medicine· Chicago, ILMedical & Surgical Specialists, LLC· Galesburg, ILCancer Care Center of Southern Indiana· Bloomington, INOncology Hematology Associates of SW Indiana· Evansville, INCommunity Regional Cancer Center· Indianapolis, ININ Onc/Hem Associates· Indianapolis, IN

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