SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial

Sponsor
Amgen
Study ID
NCT00418938
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Panitumumab — DRUG
    6mg/kg IV
  • Bevacizumab — DRUG
    Either 5mg/kg OR 10mg/kg IV
  • Leucovorin — DRUG
    400mg/m\^2 IV (in the vein)
  • Irinotecan — DRUG
    180mg/m\^2 IV (in the vein)
  • 5-Fluorouracil — DRUG
    400mg/m\^2 bolus IV (in the vein) over 2-4 min, followed by 2400mg/m\^2 continuous IV over 46 hours for the first 2 cycles, increased to 3000mg/m\^2 thereafter if no significant side effects

Study Details

This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).

Key Dates

Start date
Nov 1, 2006
Status verified
Sep 2018
Primary completion
May 10, 2012
Completion
Apr 1, 2013

Study Design

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

Arms

  • Experimental: Arm A
    FOLFIRI + Panitumumab
  • Experimental: Arm B
    FOLFIRI + Bevacizumab

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From randomization up to 65 months. ]

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