FOLFIRI or FOLFOX With or Without Cetuximab in Patients With Metastatic Adenocarcinoma of the Colon or Rectum

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cetuximab — DRUG
  IV
• 5-FU — DRUG
  IV
• irinotecan — DRUG
  IV
• leucovorin — DRUG
  IV
• oxaliplatin — DRUG
  IV

Study Details

This is a randomized phase II study trial that has served as a screening trial to test the increased efficacy of chemotherapy + cetuximab versus chemotherapy alone among patients with untreated, advanced or metastatic colon cancer regardless of tumor status with respect to EGFR.

Key Dates

Start date

Dec 31, 2003

Status verified

May 2018

Primary completion

Dec 31, 2006

Completion

Jun 30, 2010

Study Design

Enrollment

238 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: FOLFIRI
  Patients receive irinotecan 180 mg/m\^2 over 90 minutes on day 1, then leucovorin 400 mg/m\^2 over 2 hours followed by 5FU 400 mg/m\^2 IV bolus injection then 5FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours repeated every 2 weeks. One cycle of therapy is 8 weeks.
• Experimental: Arm B: FOLFIRI + C225
  Patients receive irinotecan 180 mg/m\^2 over 90 minutes, then leucovorin 400 mg/m\^2 IV over 2 hours followed by 5FU 400 mg/m\^2 IV bolus injection then 5FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours repeated every 2 weeks. Patients also receive cetuximab 400 mg/m\^2 IV over 120 minutes day 1, then 250 mg/m\^2 IV over 60 minutes weekly. All patients must be premedicated with diphenhydramine hydrochloride 50 mg (or a similar agent) IV prior to the first dose of cetuximab in an effort to prevent a hypersensitivity reaction. Premedication is recommended prior to subsequent doses, but at the Investigator's discretion the dose of diphenhydramine (or a similar agent) may be reduced.
• Active Comparator: Arm C: FOLFOX
  Patients receive oxaliplatin 85 mg/m\^2 IV infused over 120 minutes, then leucovorin 400 mg/m\^2 IV over 2 hours followed by 5 FU 400 mg/m\^2 IV bolus injection then 5 FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours every 2 weeks.
• Experimental: Arm D: FOLFOX + C225
  Patients receive oxaliplatin 85 mg/m\^2 IV infused over 120 minutes, then leucovorin 400 mg/m\^2 over 2 hours followed by 5 FU 400 mg/m\^2 IV bolus injection then 5 FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours every 2 weeks. Patients also receive cetuximab 400 mg/m\^2 IV over 120 minutes day 1, then 250 mg/m\^2 IV over 60 minutes weekly. All patients must be premedicated with diphenhydramine hydrochloride 50 mg (or a similar agent) IV prior to the first dose of cetuximab in an effort to prevent a hypersensitivity reaction. Premedication is recommended prior to subsequent doses, but at the Investigator's discretion the dose of diphenhydramine (or a similar agent) may be reduced.

Primary Outcome Measure

Overall survival [ Time Frame: Up to 3 years of follow up ]

Locations (77)

Find similar trials in Anniston, AL

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