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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Phase I FOLFOX Combination
Scientific title
A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Colorectal Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Study type
Description of intervention(s) / exposure
Treatment: Drugs - ZD6474 (vandetanib)
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Oxaliplatin

Treatment: Drugs: ZD6474 (vandetanib)
once daily oral dose

Treatment: Drugs: 5-Fluorouracil
intravenous infusion

Treatment: Drugs: Leucovorin
intravenous infusion

Treatment: Drugs: Oxaliplatin
intravenous infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
Timepoint [1] 0 0
Assessed at each visit

Key inclusion criteria
1. Histologically confirmed locally advanced, recurrent or metastatic colorectal
adenocarcinoma (Stage IV)

2. WHO performance status 0-1

3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before
entry and stable

2. last dose of prior chemotherapy discontinued at least 4 weeks before start study

3. prior unanticipated severe reaction to oxaliplatin

Study design
Purpose of the study
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
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment hospital [2] 0 0
Research Site - Footscray
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Footscray
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Genzyme, a Sanofi Company

Ethics approval
Ethics application status

Brief summary
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination
with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy
in patients with advanced colorectal adenocarcinoma.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
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
Other publications