A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT01227707
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    5 mg/kg intravenously every 2 weeks, 4 cycles
  • capecitabine [Xeloda] — DRUG
    825 mg/m2 twice daily orally, 38 days
  • Radiation therapy — RADIATION
    Total dose of 45 Gy over 38 days
  • Mesorectal excision — PROCEDURE
    6-8 weeks after completion of neoadjuvant treatment
  • bevacizumab [Avastin] — DRUG
    Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months
  • 5-fluorouracil — DRUG
    Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months
  • leucovorin — DRUG
    Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months

Study Details

This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.

Key Dates

First listed
Oct 25, 2010
Start date
Nov 30, 2005
Status verified
Jul 2015
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

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

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: 6 to 8 weeks following completion of neoadjuvant treatment ]

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