Trial Review

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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
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Mexico
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North Carolina
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Vermont
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Washington
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Wisconsin
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Anderlecht
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Bruxelles
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Wilrijk
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France
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France
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Eschweiler
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Heidelberg
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Kiel
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Leipzig
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Gyor
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Roma
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Italy
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Rozzano
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Italy
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Torino
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Netherlands
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GA Utrecht
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New Zealand
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Hamilton
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New Zealand
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Palmerston North
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Portugal
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Coimbra
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Slovakia
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Bratislava
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Kosice
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Zilina
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Spain
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Alicante
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Spain
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Madrid
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Malaga
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Spain
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Zaragoza
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Sweden
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Stockholm
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Thun
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Switzerland
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Zurich
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Switzerland
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Zürich
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Tao-Yuan
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United Kingdom
State/province [101] 0 0
Belfast
Country [102] 0 0
United Kingdom
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Leicester
Country [103] 0 0
United Kingdom
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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