Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00056446




Registration number
NCT00056446
Ethics application status
Date submitted
13/03/2003
Date registered
14/03/2003
Date last updated
6/03/2017

Titles & IDs
Public title
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum
Secondary ID [1] 0 0
CPTK787 0133/304946
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Colonic Neoplasms 0 0
Rectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 1 - Oxaliplatin/5-FU/LV and PTK787/ZK 222584

Placebo comparator: 2 - Oxaliplatin/5-FU/LV and placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
throughout duration of study
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
throughout duration of study
Secondary outcome [2] 0 0
Time to progression
Timepoint [2] 0 0
throughout duration of study
Secondary outcome [3] 0 0
Time to treatment failure
Timepoint [3] 0 0
throughout duration of study
Secondary outcome [4] 0 0
Tumor response rate
Timepoint [4] 0 0
throughout duration of study
Secondary outcome [5] 0 0
Tolerability and safety profile
Timepoint [5] 0 0
throughout duration of study

Eligibility
Key inclusion criteria
Inclusion criteria

* Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease
* One prior chemotherapy regimen with irinotecan and 5FU
* Evidence of progressive disease within 6 months after last dose of irinotecan
* WHO Performance Status of 0, 1, or 2
* Measurable tumors
* Adequate hematologic status, liver and kidney function
* Life expectancy greater than 12 weeks
* Written informed consent obtained
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

* History or presence of central nervous system disease
* Patients with a history of another primary cancer within 5 years
* Prior chemotherapy within 3 weeks before entry to study
* Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
* Investigational drugs within 4 weeks before entry to study
* Prior therapy with oxaliplatin
* Peripheral neuropathy with functional impairment
* Female patients who are pregnant or breast feeding
* Any severe or uncontrolled medical condition which could prevent participation in study
* Chronic kidney disease
* Acute or chronic liver disease
* Patients taking Coumadin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2007
Sample size
Target
Accrual to date
Final
855
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Frankston
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woodville South
Recruitment postcode(s) [1] 0 0
VIC - Frankston
Recruitment postcode(s) [2] 0 0
SA - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maine
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Missouri
Country [23] 0 0
United States of America
State/province [23] 0 0
Montana
Country [24] 0 0
United States of America
State/province [24] 0 0
Nevada
Country [25] 0 0
United States of America
State/province [25] 0 0
New Hampshire
Country [26] 0 0
United States of America
State/province [26] 0 0
New Jersey
Country [27] 0 0
United States of America
State/province [27] 0 0
New Mexico
Country [28] 0 0
United States of America
State/province [28] 0 0
New York
Country [29] 0 0
United States of America
State/province [29] 0 0
North Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Ohio
Country [31] 0 0
United States of America
State/province [31] 0 0
Oklahoma
Country [32] 0 0
United States of America
State/province [32] 0 0
Pennsylvania
Country [33] 0 0
United States of America
State/province [33] 0 0
South Carolina
Country [34] 0 0
United States of America
State/province [34] 0 0
Tennessee
Country [35] 0 0
United States of America
State/province [35] 0 0
Texas
Country [36] 0 0
United States of America
State/province [36] 0 0
Utah
Country [37] 0 0
United States of America
State/province [37] 0 0
Vermont
Country [38] 0 0
United States of America
State/province [38] 0 0
Virginia
Country [39] 0 0
United States of America
State/province [39] 0 0
Washington
Country [40] 0 0
United States of America
State/province [40] 0 0
West Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Wisconsin
Country [42] 0 0
Austria
State/province [42] 0 0
St. Veit an der Glan
Country [43] 0 0
Belgium
State/province [43] 0 0
Antwerpen
Country [44] 0 0
Belgium
State/province [44] 0 0
Brasschaat
Country [45] 0 0
Belgium
State/province [45] 0 0
Bruxelles
Country [46] 0 0
Belgium
State/province [46] 0 0
Leuven
Country [47] 0 0
Belgium
State/province [47] 0 0
Liège
Country [48] 0 0
Belgium
State/province [48] 0 0
Wilrijk
Country [49] 0 0
Brazil
State/province [49] 0 0
Porto Alegre RS
Country [50] 0 0
Brazil
State/province [50] 0 0
Salvador - Ba
Country [51] 0 0
Brazil
State/province [51] 0 0
Salvador, Bahia
Country [52] 0 0
Brazil
State/province [52] 0 0
Sao Paulo
Country [53] 0 0
Canada
State/province [53] 0 0
Alberta
Country [54] 0 0
Canada
State/province [54] 0 0
British Columbia
Country [55] 0 0
Canada
State/province [55] 0 0
Manitoba
Country [56] 0 0
Canada
State/province [56] 0 0
Nova Scotia
Country [57] 0 0
Canada
State/province [57] 0 0
Ontario
Country [58] 0 0
Canada
State/province [58] 0 0
Quebec
Country [59] 0 0
Canada
State/province [59] 0 0
Saskatchewan
Country [60] 0 0
France
State/province [60] 0 0
Avignon
Country [61] 0 0
France
State/province [61] 0 0
Boulogne Cedex
Country [62] 0 0
France
State/province [62] 0 0
Lille cedex
Country [63] 0 0
France
State/province [63] 0 0
Marseille cedex 05
Country [64] 0 0
France
State/province [64] 0 0
Montpellier cedex 5
Country [65] 0 0
France
State/province [65] 0 0
Nice cedex 2
Country [66] 0 0
France
State/province [66] 0 0
Rennes cedex
Country [67] 0 0
France
State/province [67] 0 0
Saint Herblain
Country [68] 0 0
France
State/province [68] 0 0
Strasbourg
Country [69] 0 0
France
State/province [69] 0 0
Toulouse cedex
Country [70] 0 0
Germany
State/province [70] 0 0
Augsburg
Country [71] 0 0
Germany
State/province [71] 0 0
Berlin
Country [72] 0 0
Germany
State/province [72] 0 0
Bielefeld
Country [73] 0 0
Germany
State/province [73] 0 0
Braunschweig
Country [74] 0 0
Germany
State/province [74] 0 0
Dessau
Country [75] 0 0
Germany
State/province [75] 0 0
Dresden
Country [76] 0 0
Germany
State/province [76] 0 0
Essen
Country [77] 0 0
Germany
State/province [77] 0 0
Frankfurt
Country [78] 0 0
Germany
State/province [78] 0 0
Hamburg
Country [79] 0 0
Germany
State/province [79] 0 0
Hannover
Country [80] 0 0
Germany
State/province [80] 0 0
Köln
Country [81] 0 0
Germany
State/province [81] 0 0
Magdeburg
Country [82] 0 0
Germany
State/province [82] 0 0
München
Country [83] 0 0
Germany
State/province [83] 0 0
Neumünster
Country [84] 0 0
Germany
State/province [84] 0 0
Trier
Country [85] 0 0
Germany
State/province [85] 0 0
Ulm
Country [86] 0 0
Germany
State/province [86] 0 0
Wiesbaden
Country [87] 0 0
Hong Kong
State/province [87] 0 0
ChaiWan
Country [88] 0 0
Italy
State/province [88] 0 0
Ancona
Country [89] 0 0
Italy
State/province [89] 0 0
Bergamo
Country [90] 0 0
Italy
State/province [90] 0 0
Brescia
Country [91] 0 0
Italy
State/province [91] 0 0
Cremona
Country [92] 0 0
Italy
State/province [92] 0 0
Genova
Country [93] 0 0
Italy
State/province [93] 0 0
Livorno
Country [94] 0 0
Italy
State/province [94] 0 0
Milano
Country [95] 0 0
Italy
State/province [95] 0 0
Reggio Emilia
Country [96] 0 0
Italy
State/province [96] 0 0
Roma
Country [97] 0 0
Italy
State/province [97] 0 0
Rozzano
Country [98] 0 0
New Zealand
State/province [98] 0 0
Auckland
Country [99] 0 0
New Zealand
State/province [99] 0 0
Christchurch
Country [100] 0 0
New Zealand
State/province [100] 0 0
Wellington
Country [101] 0 0
Portugal
State/province [101] 0 0
Coimbra
Country [102] 0 0
Portugal
State/province [102] 0 0
Lisboa
Country [103] 0 0
Slovakia
State/province [103] 0 0
Bratislava
Country [104] 0 0
Spain
State/province [104] 0 0
Cordoba
Country [105] 0 0
Spain
State/province [105] 0 0
Elche
Country [106] 0 0
Spain
State/province [106] 0 0
Madrid
Country [107] 0 0
Spain
State/province [107] 0 0
Malaga
Country [108] 0 0
Spain
State/province [108] 0 0
Zaragoza
Country [109] 0 0
Sweden
State/province [109] 0 0
Goteborg
Country [110] 0 0
Sweden
State/province [110] 0 0
Stockholm
Country [111] 0 0
Switzerland
State/province [111] 0 0
Bern
Country [112] 0 0
Switzerland
State/province [112] 0 0
Thun
Country [113] 0 0
Taiwan
State/province [113] 0 0
Changhua
Country [114] 0 0
Taiwan
State/province [114] 0 0
Kaohsiung
Country [115] 0 0
Taiwan
State/province [115] 0 0
Keelung
Country [116] 0 0
Taiwan
State/province [116] 0 0
Taichung
Country [117] 0 0
Taiwan
State/province [117] 0 0
Tainan
Country [118] 0 0
Taiwan
State/province [118] 0 0
Taipei
Country [119] 0 0
Taiwan
State/province [119] 0 0
Tao-Yuan
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Belfast
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Birmingham
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Cardiff
Country [123] 0 0
United Kingdom
State/province [123] 0 0
London
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.
Trial website
https://clinicaltrials.gov/study/NCT00056446
Trial related presentations / publications
Van Cutsem E, Bajetta E, Valle J, Kohne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. Epub 2011 Apr 4.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis/Schering AG, Germany
Address 0 0
Novartis / Schering AG Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00056446