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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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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/study/NCT00056446
Trial related presentations / publications
Van Cutsem E, Bajetta E, Valle J, Kohne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. 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/NCT00056446