Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer

Sponsor
Amgen
Study ID
NCT00111761
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate.
  • Panitumumab — BIOLOGICAL
    Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles.
  • 5-Fluorouracil — DRUG
    Part 1: IV bolus 500 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m\^2 and infusional 2400-3000 mg/m\^2 over 46 hours once every other week until disease progression or unable to tolerate.
  • Leucovorin — DRUG
    Part 1: IV bolus 20 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m\^2 every other week until disease progression or unable to tolerate.

Study Details

The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.

Key Dates

Start date
Jul 31, 2002
Status verified
Nov 2013
Primary completion
Feb 29, 2008
Completion
Oct 31, 2008

Study Design

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

Arms

  • Experimental: Part 1: Panitumumab + IFL
    Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen)
  • Experimental: Part 2: Panitumumab + FOLFIRI
    Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)

Primary Outcome Measure

Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2) [ Time Frame: Until disease progression (median 47 weeks) ]

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