Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer

Conditions

• Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  5 mg/kg over 30 minutes on Days 1 and 15
• Oxaliplatin — DRUG
  85 mg/m2 on Days 1 and 15
• Leucovorin — DRUG
  400 mg/m2 on Days 1 and 15
• Fluorouracil — DRUG
  400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)
• Cetuximab — DRUG
  400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour

Study Details

The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.

Key Dates

First listed

Nov 11, 2005

Start date

Sep 30, 2005

Status verified

Sep 2018

Primary completion

Jun 30, 2007

Completion

Jun 30, 2009

Study Design

Enrollment

247 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bev-FOLFOX
  (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle
• Experimental: FOLF-CB
  (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU. Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 12 months ]

Locations (82)

Find similar trials in Birmingham, AL

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