Trial Review

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/ct2/show/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
Treatment: Drugs - Vatalanib

Experimental: 1 - Oxaliplatin/5-FU/LV and PTK787/ZK 222584

Placebo Comparator: 2 - Oxaliplatin/5-FU/LV and placebo


Treatment: Drugs: Vatalanib
Intervention code [1] 0 0
Treatment: Drugs
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/ct2/show/NCT00056446
Trial related presentations / publications
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/ct2/show/NCT00056446