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/NCT00068679




Registration number
NCT00068679
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:
Breast Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

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/NCT00068679
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/NCT00068679