Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT00537823
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Cetuximab — DRUG
  • Bevacizumab — DRUG
  • Leucovorin — DRUG
  • Oxaliplatin — DRUG
  • Fluorouracil — DRUG

Study Details

The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX based therapy on postoperative problems after liver surgery for patients with metastatic colorectal cancer.

Key Dates

First listed
Oct 1, 2007
Start date
Jun 30, 2007
Status verified
Oct 2016
Primary completion
Dec 31, 2009
Completion
Jul 31, 2011

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Wildtype
    Neoadjuvant therapy Week 1 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2/day over 46 hours Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly Weeks 3, 5, 7 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2/day over 46 hours Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Week 1, 3, 5, 7, 9, 11, 13, 15 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2/day over 46 hours Weeks 2, 4, 6, 8, 10, 12, 16 \*Cetuximab 250 mg/m\^2 IV weekly
  • Experimental: Arm 2 K-Ras 12/13 codon mutation
    Neoadjuvant Therapy Weeks 1, 3, 5 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * Bevacizumab 5 mg/kg IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2 Week 7 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2 Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Weeks 1, 3, 5, 9, 11, 13 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * Bevacizumab 5 mg/kg IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2 Week 7, 15 * Leucovorin 400 mg/m\^2 IV * Oxaliplatin 85 mg/m\^2 IV * 5FU bolus 400 mg/m\^2 * 5FU CIVI 1200 mg/m\^2

Primary Outcome Measure

Postoperative Complication Rate [ Time Frame: 30 days following surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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