Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT00056459




Registration number
NCT00056459
Ethics application status
Date submitted
13/03/2003
Date registered
14/03/2003
Date last updated
10/02/2020

Titles & IDs
Public title
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo
Secondary ID [1] 0 0
CONFIRM 1
Secondary ID [2] 0 0
CPTK787 0135/306241
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
Progression free survival
Timepoint [1] 0 0
Throughout duration of study
Secondary outcome [1] 0 0
Time to progression
Timepoint [1] 0 0
Throughout duration of study
Secondary outcome [2] 0 0
Time to treatment failure
Timepoint [2] 0 0
Throughout duration of study
Secondary outcome [3] 0 0
Best overall response rate
Timepoint [3] 0 0
Throughout duration of study
Secondary outcome [4] 0 0
Tolerability and safety profile
Timepoint [4] 0 0
Throughout duration of study

Eligibility
Key inclusion criteria
Inclusion criteria:

* Patients with metastatic colorectal cancer coming for initial chemotherapy
* Documented metastatic colorectal cancer
* 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 for metastatic colorectal cancer
* Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 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 anti-VEGF agents
* Any prior therapy with oxaliplatin or allergy to platinum-containing drugs
* Peripheral neuropathy with functional impairment
* Female patients who are pregnant or breast feeding
* Any severe or uncontrolled medical conditions which could prevent participation in study
* Patients who are taking Coumadin

Other protocol-defined inclusion / exclusion criteria may apply

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
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
1168
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Garran
Recruitment hospital [3] 0 0
- Nedlands
Recruitment hospital [4] 0 0
- Wollongong
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
ACT 2605 - Garran
Recruitment postcode(s) [3] 0 0
WS 6009 - Nedlands
Recruitment postcode(s) [4] 0 0
NSW 2500 - Wollongong
Recruitment postcode(s) [5] 0 0
QLD 4102 - Woolloongabba
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
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
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maine
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
Nevada
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
United States of America
State/province [25] 0 0
New Mexico
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
North Dakota
Country [29] 0 0
United States of America
State/province [29] 0 0
Ohio
Country [30] 0 0
United States of America
State/province [30] 0 0
Oklahoma
Country [31] 0 0
United States of America
State/province [31] 0 0
Oregon
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
Wisconsin
Country [41] 0 0
Belgium
State/province [41] 0 0
Anderlecht
Country [42] 0 0
Belgium
State/province [42] 0 0
Antwerpen
Country [43] 0 0
Belgium
State/province [43] 0 0
Bruxelles
Country [44] 0 0
Belgium
State/province [44] 0 0
Gent
Country [45] 0 0
Belgium
State/province [45] 0 0
Wilrijk
Country [46] 0 0
Brazil
State/province [46] 0 0
Porto Alegre RS
Country [47] 0 0
Brazil
State/province [47] 0 0
Porto Alegre
Country [48] 0 0
Brazil
State/province [48] 0 0
Salvador
Country [49] 0 0
Brazil
State/province [49] 0 0
Sao Paulo
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Czechia
State/province [52] 0 0
Brno
Country [53] 0 0
Czechia
State/province [53] 0 0
Praha 2
Country [54] 0 0
Czechia
State/province [54] 0 0
Praha 5
Country [55] 0 0
France
State/province [55] 0 0
Marseille cedex 05
Country [56] 0 0
France
State/province [56] 0 0
Marseille Cedex 9
Country [57] 0 0
France
State/province [57] 0 0
Strasbourg
Country [58] 0 0
Germany
State/province [58] 0 0
Augsburg
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin
Country [60] 0 0
Germany
State/province [60] 0 0
Dessau
Country [61] 0 0
Germany
State/province [61] 0 0
Erlangen
Country [62] 0 0
Germany
State/province [62] 0 0
Eschweiler
Country [63] 0 0
Germany
State/province [63] 0 0
Essen
Country [64] 0 0
Germany
State/province [64] 0 0
Frankfurt
Country [65] 0 0
Germany
State/province [65] 0 0
Hannover
Country [66] 0 0
Germany
State/province [66] 0 0
Heidelberg
Country [67] 0 0
Germany
State/province [67] 0 0
Kiel
Country [68] 0 0
Germany
State/province [68] 0 0
Köln
Country [69] 0 0
Germany
State/province [69] 0 0
Leipzig
Country [70] 0 0
Germany
State/province [70] 0 0
Magdeburg
Country [71] 0 0
Hungary
State/province [71] 0 0
Budapest
Country [72] 0 0
Hungary
State/province [72] 0 0
Gyor
Country [73] 0 0
Hungary
State/province [73] 0 0
Szeged
Country [74] 0 0
Italy
State/province [74] 0 0
Forli
Country [75] 0 0
Italy
State/province [75] 0 0
Genova
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Italy
State/province [77] 0 0
Modena
Country [78] 0 0
Italy
State/province [78] 0 0
Roma
Country [79] 0 0
Italy
State/province [79] 0 0
Rozzano
Country [80] 0 0
Italy
State/province [80] 0 0
Torino
Country [81] 0 0
Netherlands
State/province [81] 0 0
GA Utrecht
Country [82] 0 0
New Zealand
State/province [82] 0 0
Hamilton
Country [83] 0 0
New Zealand
State/province [83] 0 0
Palmerston North
Country [84] 0 0
Portugal
State/province [84] 0 0
Coimbra
Country [85] 0 0
Slovakia
State/province [85] 0 0
Bratislava
Country [86] 0 0
Slovakia
State/province [86] 0 0
Kosice
Country [87] 0 0
Slovakia
State/province [87] 0 0
Zilina
Country [88] 0 0
Spain
State/province [88] 0 0
Alicante
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
Spain
State/province [90] 0 0
Malaga
Country [91] 0 0
Spain
State/province [91] 0 0
Zaragoza
Country [92] 0 0
Sweden
State/province [92] 0 0
Stockholm
Country [93] 0 0
Switzerland
State/province [93] 0 0
Basel
Country [94] 0 0
Switzerland
State/province [94] 0 0
Bern
Country [95] 0 0
Switzerland
State/province [95] 0 0
Thun
Country [96] 0 0
Switzerland
State/province [96] 0 0
Zurich
Country [97] 0 0
Switzerland
State/province [97] 0 0
Zürich
Country [98] 0 0
Taiwan
State/province [98] 0 0
Tainan
Country [99] 0 0
Taiwan
State/province [99] 0 0
Taipei
Country [100] 0 0
Taiwan
State/province [100] 0 0
Tao-Yuan
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Belfast
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Leicester
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00056459