Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT01004159
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • cetuximab with irinotecan — DRUG
    Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment

Study Details

This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer

Key Dates

Start date
Sep 30, 2009
Status verified
Sep 2015
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cetuximab with irinotecan

Primary Outcome Measure

12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer [ Time Frame: 12 week ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-

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