EUCTR2013-000858-22-IT
Active, not recruiting
Not Applicable
A Single-Arm, Open Label Study of Aflibercept as Maintenance Therapy Following Induction with Aflibercept in Combination with XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient - AMOR
ConditionsColorectal cancer metastaticMedDRA version: 16.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsZaltrap
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal cancer metastatic
- Sponsor
- Sanofi-Aventis Groupe
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically or cytologically\-proven adenocarcinoma of the colon or rectum.
- •\- Metastatic disease not amenable to potentially curative treatment (i.e. unresectable).
- •\- Measurable lesion as assessed by RECIST criteria
- •\- No prior systemic anti\-cancer treatment for metastatic disease
- •\- No prior adjuvant treatment after resection of distant metastases
- •\- No prior treatment with angiogenesis inhibitors
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 61
Exclusion Criteria
- •\- Age \<18 years
- •\- Eastern Cooperative Oncology Group Performance status \>/\= 2
- •\- Less than 4 weeks from prior radiotherapy or prior surgery (or until the surgical wound is fully healed)
- •\- Treatment with any other investigational product within the prior 28 days
- •\- Other prior neoplasm
- •\- History of brain metastases, active seizure disorder, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
- •\- Any of the following within the prior 6 months: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, severe congestive heart failure, stroke or transient ischemic attack.
- •\- Any of the following within the prior 3 months: moderate/severe gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event
- •\- Deep vein thrombosis within the prior 4 weeks
- •\- Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study
Outcomes
Primary Outcomes
Not specified
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