Trial Information

Summary: A Study of Xeloda (Capecitabine) as a First-Line Therapy in Patients With Metastatic Colorectal Cancer

Status: No longer recruiting

Protocol Number: NO16966

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study comparing the effect of first-line treatment with intermittent Xeloda versus fluorouracil/leucovorin, both in combination with Eloxatin with or without Avastin, on tumor progression in patients with metastatic colorectal cancer

Brief Summary: This 4 arm study will assess the efficacy and safety of oral Xeloda, or intravenous (iv) fluorouracil/leucovorin, in combination with iv Eloxatin (oxaliplatin) with or without iv Avastin as a first-line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin), in 3 week cycles, 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles), 3) XELOX + Avastin (7.5 mg iv on day 1)in 3 week cycles or 4)FOLFOX-4 + Avastin (5mg iv on day 1)in 2 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals. Target sample size is 1920.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: capecitabine [Xeloda]

Primary Outcome: 1. Non-inferiority of XELOX vs FOLFOX, with respect to time to progression or death, and superiority of Avastin vs placebo. Time frame: Event driven

Key Secondary Outcomes: 1. Overall survival, overall response rate, time to response, duration of response, time to treatment failure. Time frame: Event driven 2. AEs, laboratory tests. 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, 2003

Trial Registration Date: 06/24/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:21:33 PM