OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

Arms (1)

1. type

   EXPERIMENTAL

   label

   1

   interventionNames

   1. Drug: bevacizumab [Avastin]
   2. Drug: Oxaliplatin
   3. Drug: Xeloda

Primary outcomes (2)

1. measure

   Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death

   timeFrame

   Baseline and Day 1 of every cycle until disease progression or death up to 5 years

   description

   PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.