Trial Information

Summary: A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

Status: No longer recruiting

Protocol Number: ML18491

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of 2 different treatment schedules of Xeloda with Eloxatin and Avastin on progression-free survival in treatment-naïve patients with locally advanced or metastatic colorectal cancer

Brief Summary: This 2 arm study will evaluate the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous Eloxatin (oxaliplatin) and intravenous bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients will be randomized to receive either 1)Xeloda 850mg/m2 po bid on days 1-14, oxaliplatin 130mg/m2 iv on day 1, and Avastin 7.5mg/kg iv on day 1 of each 3 week cycle or 2)Xeloda 1500mg/m2 po bid on days 1-7, oxaliplatin 85mg/m2 iv on day 1 and Avastin 5mg/kg iv on day 1 of each 2 week cycle. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 430.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: capecitabine [Xeloda]

Primary Outcome: 1. Progression-free survival or death Time frame: Event driven

Key Secondary Outcomes: 1. Overall response rate, survival time, duration of response, time to treatment failure, rate of complete surgical resection. Time frame: Event driven 2. QoL, AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2005

Trial Registration Date: 08/31/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:18:57 PM