Colorectal Cancer Metastatic Clinical Trial
— AMOROfficial title:
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
Verified date | April 2015 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Primary Objectives:
Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and
capecitabine (XELOX) combination to be used in the Part 2 of the study.
Study Part 2: To assess the percentage of patients without progression of the disease at 6
months after the start of maintenance therapy with aflibercept single-agent, following the
first-line induction therapy with XELOX and aflibercept combination in patients with
previously untreated metastatic colorectal cancer.
Secondary Objective:
Study Part 2: Include the evaluation of progression free survival, overall survival,
response to treatment, the overall safety (during induction and maintenance therapy) and the
assessment of aflibercept pharmacodynamics and biomarkers parameters.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. 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. - Inadequate bone marrow, liver and renal function: neutrophils < 1.5x10^9/L, platelets < 100x10^9/L, hemoglobin < 9.0 g/dL, total bilirubin >1.5 x upper normal limit (ULN), transaminases >3 x ULN (unless liver metastasis are present), alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum creatinine > 1.5 x ULN. - Patients on anticoagulant therapy with warfarin. - Symptomatic peripheral sensory neuropathy. - Inability to take oral medications. - Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, malabsorption syndrome, unresolved bowel obstruction/sub-obstruction, surgery more extensive than hemicolectomy, extensive small intestine resection with chronic diarrhea. - Known dihydropyrimidine dehydrogenase deficiency. - known history of hypersensitivity to aflibercept. - Any contraindication to administer oxaliplatin or capecitabine as per package insert of each drug. - Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria > 500 mg/24-h. - Uncontrolled hypertension within the prior 3 months. - Evidence of clinically significant bleeding predisposition or underlying coagulopathy, non-healing wound. - Pregnant or breast-feeding women. - Patients with reproductive potential who do not agree to use an accepted effective method of contraception. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Investigational Site Number 380-001 | Genova | |
Italy | Investigational Site Number 380-002 | Milano |
Lead Sponsor | Collaborator |
---|---|
Sanofi | Regeneron Pharmaceuticals |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study Part 1: treatment related Dose Limiting Toxicity(ies) (DLTs) observed at first cycle | At 3 weeks (completion of first cycle) for patients included in dose-escalation study Part 1 | Yes | |
Primary | Study Part 2: proportion of patients alive without progression at 6 months after the start of the maintenance therapy | 6 months after the start of the maintenance therapy | No | |
Secondary | Study Part 1: number of patients reporting adverse events or laboratory abnormalities per each dose level tested | At each cycle, at 30 days after the last treatment, up to an estimation of 34 weeks | Yes | |
Secondary | Study Part 1: Tumor response category: Complete Response (CR), Partial Response (PR), No Change (NC) or Progressive Disease (PD) | Every 9 weeks from treatment start up to the first documentation of disease progression | No | |
Secondary | Study Part 2: Progression free survival | Study period, approximately 2.5 years | No | |
Secondary | Study Part 2: Overall survival | Study period, approximately 2.5 years | No | |
Secondary | Study Part 2: Proportion of patients reaching a total metastases resection (if applicable) | Up to 12 months after the end of study enrollment | No | |
Secondary | Study Part 2: Proportion of patients with complete or partial response as defined in RECIST 1.1 criteria | Up to 12 months after the end of study enrollment | No | |
Secondary | Study Part 2: Number of patients reporting adverse events or laboratory abnormalities as per NCI-CTCAE 4.03 criteria | Every cycle up to 30 days after the last treatment administration, study period | Yes | |
Secondary | Study Part 2: Aflibercept pharmacodynamic parameters evaluation | Up to an average of 34 weeks | No | |
Secondary | Study Part 2: Aflibercept biomarkers evaluation | Up to an average of 34 weeks | No |
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