Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 target lesion;
- failed first-line chemotherapy with 5-fluorouracil and irinotecan.
Exclusion criteria:
- previous treatment with oxaliplatin;
- progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Bruxelles
- Gent
- Kortrijk
- Mont-Godinne
Canada
- Edmonton, AB
- St John'S
- Halifax, NS
- London, ON
- Oshawa, ON
- Ottawa, ON
- Thunder Bay, ON
- Toronto, ON
- Laval, QC
- Levis, QC
- Montreal, QC
- Quebec City, QC
- Regina, SK
Croatia
Finland
France
- Avignon
- Bordeaux
- Chambray-Lès-Tours
- Limoges
- Nimes
- Paris
Germany
Greece
Israel
- Beer Sheva
- Jerusalem
- Kfar Saba
- Petah Tikva
- Ramat Gan
- Tel Aviv
Italy
Korea, Republic of
Poland
Serbia and Montenegro
Slovakia
Slovenia
South Africa
- Cape Town
- Durban
- Pietermaritzburg
- Port Elizabeth
- Pretoria
Spain
- Barcelona
- Leganes
- Madrid
- Palma de Mallorca
Taiwan
United Kingdom
- Denbigh
- Manchester
- Merseyside
- Preston
- Sutton
United States
- Bakersfield, CA
- Washington, DC
- Terre Haute, IN
- St Louis, MO
- Billings, MT
- Omaha, NE
- Nyack, NY
- Fort Worth, TX
