Cancer, Colorectal
Conditions
Keywords
colorectal, cancer, zactima
Brief summary
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.
Interventions
DRUGVandetanib
once daily oral tablet two dose strengths
DRUGFOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Progression on or following treatment for metastatic colorectal cancer * Have failed therapy with an irinotecan and fluoropyrimidine containing regimen * Have World Health Organisation (WHO) performance status 0-2 and life expectancy \>12 weeks
Exclusion criteria
* Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab) * Previous adjuvant therapy with irinotecan within 12 months of randomisation * More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With an Objective Disease Progression Event | RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days) | Number of patients with objective disease progression or death (by any cause in the absence of objective progression) |
Countries
France, Hungary, Slovakia, South Korea, Spain, Taiwan
Participant flow
Recruitment details
First patient randomised 19 March 2007, last patient randomised 11 Nov 2007, data cut off date 8 March 2008. 109 patients were enrolled in the study.
Pre-assignment details
109 patients were enrolled/screened to the study but only 104 patients were entered treatment/randomized.
Participants by arm
| Arm | Count |
|---|---|
| Vandetanib 100 mg Plus FOLFOX vandetanib 100 mg plus FOLFOX | 32 |
| Vandetanib 300 mg Plus FOLFOX vandetanib 300 mg plus FOLFOX | 35 |
| Placebo Plus FOLFOX placebo plus FOLFOX | 37 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 6 | 4 |
| Overall Study | Condition under investigation worsened | 21 | 23 | 19 |
| Overall Study | Other | 1 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Vandetanib 100 mg Plus FOLFOX | Vandetanib 300 mg Plus FOLFOX | Placebo Plus FOLFOX | Total |
|---|---|---|---|---|
| Age, Continuous | 57 Years | 58 Years | 59 Years | 58 Years |
| Sex: Female, Male Female | 16 Participants | 11 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 16 Participants | 24 Participants | 24 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 32 | 32 / 35 | 35 / 37 |
| serious Total, serious adverse events | 6 / 32 | 10 / 35 | 4 / 37 |
Outcome results
Primary
Number of Patients With an Objective Disease Progression Event
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Time frame: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vandetanib 100 mg Plus FOLFOX | Number of Patients With an Objective Disease Progression Event | 23 Participants |
| Vandetanib 300 mg Plus FOLFOX | Number of Patients With an Objective Disease Progression Event | 27 Participants |
| Placebo Plus FOLFOX | Number of Patients With an Objective Disease Progression Event | 24 Participants |