A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab

Part of paid clinical trials in Vallejo, California.

Sponsor
Eli Lilly and Company
Study ID
NCT00845039
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Cetuximab — BIOLOGICAL
    Cetuximab 500 mg/m² every 14 days until disease progression or participant intolerance
  • Irinotecan — DRUG
    180 mg/m² every 14 days until disease progression or participant intolerance
  • IMC-A12 (cixutumumab) — BIOLOGICAL
    IMC-A12 10 mg/kg every 14 days until disease progression or participant intolerance

Study Details

The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC).

Key Dates

Start date
May 31, 2009
Status verified
Jun 2018
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cetuximab + Irinotecan
    Participants in Treatment Group 1 will receive intravenous infusions of Cetuximab 500 milligrams per square meter (mg/m²) and Irinotecan 180 mg/m².
  • Experimental: Cetuximab + IMC-A12 + Irinotecan
    Participants in Treatment Group 2 will receive intravenous infusions of Cetuximab 500 mg/m², IMC-A12 10 milligrams/kilogram (mg/kg) and Irinotecan 180 mg/m².

Primary Outcome Measure

Progression-Free Survival (PFS) Rate at 18 Weeks [ Time Frame: Approximately 18 Weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
ImClone Investigational SiteVallejoCalifornia94589-
ImClone Investigational SiteGreenvilleNorth Carolina27834-
ImClone Investigational SiteScrantonPennsylvania18510-

Find similar trials in Vallejo, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
ImClone Investigational Site· Vallejo, CAImClone Investigational Site· Greenville, NCImClone Investigational Site· Scranton, PA

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