Metastatic colorectal cancer
Conditions
Interventions
Trade Name: Zaltrap
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Aflibercept
Other descriptive name: AFLIBERCEPT
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Hellenic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with histologically documented adenocarcinomas of colon or rectum with unresectable metastatic disease. • No prior treatment for metastatic disease • Metastatic liver disease assessable with diffusion-weighted MR Imaging. • No previous treatment with bevacizumab or Cetuximab or Panitumumab. • Patients may have receive fluoropyrimidines with or without oxaliplatin as adjuvant treatment, if they have progressed > 12 months after the end of the last cycle of the adjuvant treatment • Performance Status (ECOG) 0-2 • Life expectancy = 3 months. • Effective contraception for both male and female subjects if the risk of conception exists. • Adequate laboratory parameters: Absolute neutrophils count = 1.5 x 109 /L, Platelets = 100 x 109 /L, Leucocytes > 3,000/mm; Hemoglobin> 10.5g/dl, creatinine clearance = 60 ml/min, Proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Known hypersensitivity reaction to the component of the treatment. • Inability to underwent a diffusion-weighted MR Imaging at baseline and in predefined time points • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. • History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy), • Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), • Treatment with any other investigational medicinal product within 28 days prior to study entry. • Other serious and uncontrolled non-malignant disease • Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy. • Gilbert's syndrome • Intolerance to atropine sulfate or loperamide • Known dihydropyrimidine dehydrogenase deficiency • Treatment with CYP3A4 inducers unless discontinued > 7 days prior to randomization • Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis • Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days • INR in absence of anticoagulation therapy > 1.25 or poorly controlled anti-coagulation therapy on coumadin or heparin compounds (INR >3.0) • History of myocardial infarction and/or stroke within 6 months prior to randomization, NYHA class III and IV congestive heart failure • History of life threatening (grade 4) venous thromboembolic events (including pulmonary embolism) within 6 months prior to registration, • Bowel obstruction • Legal incapacity or limited legal capacity. • Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent. • A second primary tumour other than non-melanoma skin cancer or in situ cervical cancer. • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on chest CT scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the objective response rates (CR and PR) of FOLFIRI plus aflibercept as 1st line treatment in patients with mCRC.;Secondary Objective: •To evaluate the progression-free survival (PFS) in patients with mCRC who achieved complete or partial response or stable disease after 1st-line treatment with FOLFIRI plus aflibercept. •To assess the median overall survival in the study population •To evaluate the safety of FOLFIRI plus aflibercept in patients with mCRC. ;Primary end point(s): To evaluate the objective response rates (CR and PR) of FOLFIRI plus aflibercept as 1st line treatment in patients with mCRC.;Timepoint(s) of evaluation of this end point: To be evaluated at the end of the study. It will also be an interim analysis of the first 30 evaluable patients will be included in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To evaluate the progression-free survival (PFS) in patients with mCRC who achieved complete or partial response or stable disease after 1st-line treatment with FOLFIRI plus aflibercept. •To assess the median overall survival in the study population •To evaluate the safety of FOLFIRI plus aflibercept in patients with mCRC.;Timepoint(s) of evaluation of this end point: To be evaluated at the end of the study. It will also be an interim analysis of the first 30 evaluable patients will be included in the study. | — |
Countries
Greece
Contacts
Public ContactIoannis Athanasakis
Hellenic Oncology Research Group
Outcome results
None listed