A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00577109
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    5mg/kg iv on day 1 of each 2 week cycle
  • Irinotecan — DRUG
    180mg/m2 iv on day 1 of each 2 week cycle
  • Leucovorin — DRUG
    200mg/m2 iv on day 1 of each 2 week cycle
  • 5 FU — DRUG
    400mg/m2 iv on day 1 of each 2 week cycle
  • Cetuximab — DRUG
    Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle

Study Details

This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.

Key Dates

Start date
Dec 31, 2007
Status verified
Aug 2016
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Progression-free survival [ Time Frame: 12 months ]

Related Studies