Advanced Colorectal Carcinoma
Conditions
Keywords
ZD6474, FOLFOX, colorectal, adenocarcinoma
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.
Interventions
DRUGLeucovorin
intravenous infusion
DRUGOxaliplatin
intravenous infusion
once daily oral dose
DRUG5-Fluorouracil
intravenous infusion
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 techniques
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 treatment 3. prior unanticipated severe reaction to oxaliplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin | Assessed at each visit |
Countries
Australia
Outcome results
None listed