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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)
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- Adelaide
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- Garran
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- Nedlands
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- Wollongong
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- 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
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Alabama
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Tainan
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Taipei
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Belfast
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Leicester
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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
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 are seeking first chemotherapy treatment
Trial website
https://clinicaltrials.gov/study/NCT00056459
Trial related presentations / publications
Hecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. 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/NCT00056459