Colorectal Cancer
Conditions
Keywords
Colon Cancer, Rectal Cancer
Brief summary
The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.
Interventions
DRUGVandetanib
once daily oral tablet two doses
DRUGFOLFIRI
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
* Histologically confirmed colorectal cancer * Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as: * Progression on or following treatment for metastatic colorectal cancer * Progression within 12 months of adjuvant chemotherapy for colorectal cancer
Exclusion criteria
* Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab. * Previous adjuvant therapy with irinotecan within 12 months of randomization * 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 | 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 (28 March 2008 +/-3 days) | Number of patients with objective disease progression or death (by any cause in the absence of objective progression) |
Countries
Argentina, Norway, South Korea, Spain, United Kingdom, United States
Participant flow
Recruitment details
First patient randomised 14 March 2007, last patient randomised 21 Jan 2008, data cut off data 31 March 2008
Participants by arm
| Arm | Count |
|---|---|
| Vandetanib 100 mg Plus FOLFIRI vandetanib 100 mg plus FOLFIRI | 35 |
| Vandetanib 300 mg Plus FOLFIRI vandetanib 300 mg plus FOLFIRI | 36 |
| Placebo Plus FOLFIRI placebo plus FOLFIRI | 35 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 11 | 9 |
| Overall Study | Condition under investigation worsened | 17 | 13 | 18 |
| Overall Study | Other | 2 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 1 |
Baseline characteristics
| Characteristic | Vandetanib 300 mg Plus FOLFIRI | Placebo Plus FOLFIRI | Total | Vandetanib 100 mg Plus FOLFIRI |
|---|---|---|---|---|
| Age, Continuous | 57 years | 59 years | 58 years | 57 years |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 43 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 20 Participants | 63 Participants | 20 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 | 32 / 35 | 36 / 36 | 34 / 35 |
| serious Total, serious adverse events | 8 / 35 | 13 / 36 | 12 / 35 |
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: 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 (28 March 2008 +/-3 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vandetanib 100 mg Plus FOLFIRI | Number of Patients With an Objective Disease Progression Event | 20 Participants |
| Vandetanib 300 mg Plus FOLFIRI | Number of Patients With an Objective Disease Progression Event | 24 Participants |
| Placebo Plus FOLFIRI | Number of Patients With an Objective Disease Progression Event | 24 Participants |