Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00354978
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 5-Fluorouracil — DRUG
    400 mg/m\^2 injection by vein Day 1 of 14 day cycle immediately after completion of leucovorin infusion. 2.4 g/m\^2 by vein over 46 hours over Days 1-3 of 14 day cycle immediately after completion of 400 mg/m\^2 injection.
  • Bevacizumab — DRUG
    5 mg/kg over 90 minutes on Day 1 of first 14 day cycle as initial dose, administered alone without other drugs. 5 mg/kg by vein on Day 1 of 14 day cycle.
  • Leucovorin — DRUG
    400 mg/m\^2 over 2-4 minutes by vein on Day 1 of 14 day cycle.
  • Irinotecan — DRUG
    180 mg/m\^2 by vein over 90 minutes on Day 1 of 14 day cycle.

Study Details

Objectives: 1. To estimate progression-free survival (PFS) at 12 months in subjects with metastatic colorectal cancer who receive FOLFIRI \[folinic acid (leucovorin or LV), 5-Fluorouracil (5-FU), irinotecan) plus bevacizumab as first line treatment. 2. To determine the objective response rate and the duration of objective response in this population. 3. To assess overall survival (OS) in this population. 4. To measure the effect of treatment on intratumoral blood volume and microvascular permeability by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in consenting patients in whom it is technically feasible. 5. To correlate plasma proteomics with response. 6. To assess the safety of this regimen.

Key Dates

Start date
Jan 31, 2005
Status verified
Sep 2011
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFIRI plus Bevacizumab
    FOLFIRI \[folinic acid (leucovorin) 400 mg/m\^2 by vein (IV) Day 1; 5-FU 400 mg/m\^2 IV injection Day 1 immediately followed by 2.4 g/m\^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m\^2 IV on Day 1\] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.

Primary Outcome Measure

Median Progression-free Survival (PFS) [ Time Frame: From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lyndon Baines Johnson General HospitalHoustonTexas77030-
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Lyndon Baines Johnson General Hospital· Houston, TXUT MD Anderson Cancer Center· Houston, TX

Related Studies