Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT00921661
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 study.
* 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 or isovorin.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00921661
Study Brief:
Protocol Section:
NCT00921661