Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Untreated Unresectable Liver-only Metastases From Colorectal Cancer

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT01022541
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Capecitabine 1700mg/m2/day in two divided doses to be administered orally for 14 days followed by 7 days rest. For 4 courses initially. (For patients aged 75+ 1300mg/m2/day in two divided doses or 650mg/m2 twice daily) Courses as per detailed description above.
  • Oxaliplatin — DRUG
    Oxaliplatin 130mg/m2 diluted in 5% dextrose will be given as an i.v. infusion over 2 hours. This will be administered on day 1 after bevacizumab. For 4 courses. (Patients aged 75+ should receive oxaliplatin at a reduced dose i.e. 100mg/m2) Courses as per detailed description above.
  • Bevacizumab — DRUG
    Bevacizumab at a dose of 7.5 mg/kg, diluted in normal saline, will be administered as an iv infusion over 30 to 90 minutes before the administration of oxaliplatin on day 1 of every cycle. The first infusion should be administered over 90 minutes. If well tolerated, the second infusion can be administered over 60 minutes. Provided that this is tolerated subsequent infusions can be administered over 30 minutes. If a patient experiences an infusion related adverse event with the 60 minute infusion, all subsequent infusions will be administered over 90 minutes. If a patient experiences an infusion related reaction with the 30 minute infusion, all subsequent infusions will be administered over 60 minutes Courses as per detailed description above.
  • Liver metastasectomy — PROCEDURE
    Patients with liver metastases which have become resectable and in whom surgery is still deemed appropriate should proceed to surgery after a 6 week interval from the last administration of capecitabine chemotherapy (at least 8 weeks from last administration of bevacizumab).

Study Details

To evaluate the overall response rate of patients with previously untreated unresectable liver-only metastases from colorectal cancer treated with neoadjuvant capecitabine and oxaliplatin plus bevacizumab.

Key Dates

First listed
Dec 1, 2009
Start date
Jun 30, 2006
Status verified
May 2013
Primary completion
Dec 31, 2010
Completion
Feb 28, 2015

Study Design

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

Arms

  • Other: This is a single arm study
    This is a single arm study

Primary Outcome Measure

Overall response rates [ Time Frame: 12 months ]

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