Clinical trial NCT00069108: A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Official title: An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2003-09-18
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Progression Free Survival Based on Independent Review Committee Assessment
timeFrame: Up to 3 years
measure: Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
timeFrame: Up to 3 years
measure: Progression Free Survival Based on Treatment Analysis- Per Population
timeFrame: Up to 3 years
measure: Best Overall Response, Investigators' Assessments
timeFrame: Up to 3 years
measure: Best Overall Response, Independent Review Committee Assessment
timeFrame: Up to 3 years
measure: Overall Survival
timeFrame: Up to 3 years
measure: Time To Response
timeFrame: Up to 3 years
measure: Duration Of Response
timeFrame: Up to 3 years
measure: Time To Treatment Failure
timeFrame: Up to 3 years
measure: Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Terre Haute
country: United States
state: Indiana
city: St Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Nyack
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Mont-godinne
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Saint Catherines
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Weston
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Levis
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Split
country: Croatia
city: Zagreb
country: Croatia
city: Tampere
country: Finland
city: Turku
country: Finland
city: Avignon
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Chambray-lès-tours
country: France
city: Limoges
country: France
city: Nimes
country: France
city: Pessac
country: France
city: Rouen
country: France
city: Tübingen
country: Germany
city: Heraklion
country: Greece
city: Thessaloniki
country: Greece
city: Beer Sheva
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Ramat-gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Bergamo
country: Italy
city: Cattolica
country: Italy
city: Rimini
country: Italy
city: Udine
country: Italy
city: Buchun
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: San Juan
country: Puerto Rico
city: Belgrade
country: Serbia
city: Bratislava
country: Slovakia
city: Ljubljana
country: Slovenia
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Pietermaritzburg
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Leganes
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Kueishan
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Denbigh
country: United Kingdom
city: Manchester
country: United Kingdom
city: Merseyside
country: United Kingdom
city: Preston
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: