Colorectal Cancer
Conditions
Brief summary
This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Interventions
DRUGFOLFIRI
standard iv chemotherapy
DRUGRO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
DRUGcetuximab
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Carcinoma of the colon and/or rectum * Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease * ECOG performance status 0-1 * Adequate hematological, renal and liver function
Exclusion criteria
* Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR) * Prior treatment with irinotecan * Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief) * CNS metastasis * History of or active autoimmune disorders/conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria | approximately 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria | approximately 18 months |
| Duration of response: time from complete or partial response to disease progression or death | approximately 18 months |
| Safety: Incidence of adverse events | approximately 18 months |
| Overall survival | approximately 18 months |
| Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa | approximately 18 months |
| Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria | approximately 18 months |
Countries
Australia, Belgium, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Outcome results
None listed