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SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial

NCT00418938 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2018-10-17

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Panitumumab

6mg/kg IV

DRUG

Bevacizumab

Either 5mg/kg OR 10mg/kg IV

DRUG

Leucovorin

400mg/m\^2 IV (in the vein)

DRUG

Irinotecan

180mg/m\^2 IV (in the vein)

DRUG

5-Fluorouracil

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-01
Primary Completion
2012-05-10
Completion
2013-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00418938 on ClinicalTrials.gov