Trial Information

Summary: A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

Status: Completed

Protocol Number: NO16967

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of intermittent Xeloda versus iv fluorouracil/leucovorin, both in combination with Eloxatin, on tumor progression in patients with metastatic colorectal cancer who received prior CPT-11 and 5-fluorouracil/leucovorin

Brief Summary: This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU 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 610.

Study Phase: III

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. Time to tumor progression 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 outcomes Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

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 2:21:53 PM