A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer
- Patients with histologically or cytologically proven malignant tumor of the colon or
rectum which is metastatic and inoperable.
- Patients must have received at least one prior line of treatment with any standard of
care, who have failed the treatment, or who have not been eligible for standard of
care for safety reasons.
- Treatment with chemotherapy, hormone therapy, radiotherapy, surgery, blood products,
or any investigational agent within 28 days.
- ECOG Performance Status>1
- Anticipated need for a major surgical procedure or radiation therapy during the
- Uncontrolled malignant ascites.
- History of brain metastases, spinal cord compression, or carcinomatous meningitis or
new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
- Pregnant or breast-feeding women.
- Uncontrolled hypertension
- Patients who have previously been treated with aflibercept
- History of abdominal fistula, GI perforation, or intra-abdominal abscess within the
past 28 days.
- History of hypersensitivity to any recombinant proteins, irinotecan, fluoropyrimidine
- Known dihydropyrimidine dehydrogenase deficiency.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.