Trial information

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 type: Interventional; Treatment; Randomized; Open Label; Active; Factorial; Safety/Efficacy study

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:

• adult patients >=18 years of age;
• metastatic colorectal cancer;
• >=1 target lesion.

Exclusion criteria:

• previous treatment with oxaliplatin or bevacizumab;
• previous systemic chemotherapy or immunotherapy for advanced or metastatic disease;
• progressive disease during or within 6 months of completion of previous adjuvant therapy.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: July, 2003

Trial registration date: 06/24/2005

Date last updated: 9/29/2008

Link to trial result

This trial was conducted at the following locations:

Australia

• Adelaide
• Brisbane
• Fitzroy
• Malvern
• Melbourne
• Perth
• Port Macquarie
• St. Leonards
• Sydney

Austria

• Wels
• Wien

Brazil

• Jaú
• Rio De Janeiro
• Sao Paulo

Canada

• Calgary, AB
• Edmonton, AB
• Kelowna, BC
• North Vancouver, BC
• Surrey, BC
• Vancouver, BC
• Victoria, BC
• Winnipeg, MB
• Hamilton, ON
• Mississauga, ON
• Oshawa, ON
• Ottawa, ON
• St. Catharines, ON
• Toronto, ON
• Levis, QC
• Montreal, QC
• Quebec City, QC

China

• Beijing
• Guangdong
• Guangzhou
• Hong Kong
• Jiangsu
• Jiangxi
• Shandong
• Shanghai
• Tianjin
• Wuhan

Czech Republic

• Brno
• Chomutov
• Ostrava

Denmark

• Herlev
• Odense

Finland

• Helsinki
• Tampere
• Turku

France

• Besancon
• Bobigny
• Boulogne-Billancourt
• Colmar
• Dijon
• Grenoble
• Nice
• Nimes
• Paris
• Pierre Benite
• Rouen
• Saint Herblain

Germany

• Bochum
• Halle
• Hannover
• Herne
• Leipzig
• Mainz
• Mannheim
• Regensburg
• Trier

Greece

• Heraklion
• Thessaloniki

Guatemala

• Guatemala City

Hungary

• Budapest
• Gyor
• Kecskemet

Ireland

• Cork
• Dublin
• Galway

Israel

• Haifa
• Jerusalem
• Petah Tikva
• Tel Aviv
• Zerifin

Italy

• Ancona
• Genova
• Modena
• Padova
• Parma
• Pavia
• Reggio Emilia
• Sassari

Korea, Republic of

• Seoul

Mexico

• Mexico City
• Tlalpan

New Zealand

• Christchurch

Norway

• Bergen
• Oslo
• Tromsø

Panama

• Panama City

Portugal

• Beja
• Lisboa

Russian Federation

• Moscow
• St Petersburg

South Africa

• Cape Town
• Pretoria
• Sandton

Spain

• Barcelona
• Córdoba
• Granada
• Leganes
• Madrid
• Malaga
• Santander
• Valencia
• Zaragoza

Sweden

• Gaevle
• Karlstad
• Stockholm
• Uppsala
• Västerås

Switzerland

• Geneve

Taiwan

• Kueishan
• Taipei

Thailand

• Bangkok
• Khon Kaen

Turkey

• Istanbul
• Izmir

United Kingdom

• Aberdeen
• Birmingham
• Derby
• Glasgow
• Guildford
• Hull
• London
• Maidstone
• Newcastle upon Tyne
• Northwood
• Nottingham
• Plymouth
• Salisbury
• Southampton
• Sutton
• Taunton

United States

• Berkeley, CA
• Fountain Valley, CA
• Greenbrae, CA
• Los Angeles, CA
• San Diego , CA
• Norwich, CT
• Waterbury, CT
• Boca Raton, FL
• Gainesville, FL
• Jacksonville, FL
• Atlanta, GA
• New Orleans, LA
• Scarborough, ME
• Boston, MA
• Ann Arbor, MI
• St Louis Park, MN
• Las Vegas, NV
• East Orange, NJ
• Hamilton, NJ
• New Brunswick, NJ
• Albuquerque, NM
• Farmington, NM
• Rochester, NY
• Syracuse, NY
• Charlotte, NC
• Bismarck, ND
• Upland, PA
• San Juan, PR
• Providence, RI
• Columbia, SC
• Memphis , TN
• Houston, TX
• Burlington, VT