Metastatic colorectal cancer MedDRA version: 19.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Zaltrap
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Aflibercept
Other descriptive name: AFLIBERCEPT
Concentration unit: mg/kg milligram(s)/kilogram
Conc
Sponsors
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent form signed and dated, and willingness and ability to accomplish the protocol requirements. 2. Histologically confirmed Adenocarcinoma of the colon and / or rectum 3. Diagnosed metastatic disease. 4. Evidence of at least one measurable lesion using one-dimensional CT or MRI according to RECIST criteria, version 1.1. 5. Patients with metastatic colorectal cancer (MCRC) that is resistant or has progressed after treatment with oxaliplatin. 6. Age = 18 years. 7. Functional status (EF) of the World Health Organization (WHO) of 0 to 2. 8. Adequate bone marrow function: neutrophils (ANC) = 1.5 x 109 / l; platelets = 100 x 109 / l; hemoglobin = 9 g / dl. 9. Adequate renal function: serum creatinine level =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypercalcemia. 2. Pre-existing permanent Neuropathy (NCI grade> 2). 3. Uncontrolled hypertension (defined as systolic blood pressure > 150 mm Hg and / or diastolic blood pressure> 100 mm Hg) or history of hypertensive crisis or hypertensive encephalopathy. 4. Concomitant antineoplastic treatment non-scheduled in the protocol (e.g., chemotherapy, targeted molecular therapy, immunotherapy). 5. Treatment with any other investigational product within 28 days prior to inclusion in the study. 6. Another serious and uncontrolled non-malignant disease 7. History or evidence of CNS metastases on physical examination, unless it is properly treated (e.g., non-irradiated CNS metastases, convulsion uncontrolled with standard medical treatment). 8. Diagnosis of Gilbert's syndrome. 9. Atropine sulfate or loperamide intolerance. 10. Diagnosis of dihydropyrimidine dehydrogenase deficiency. 11. Treatment with inducers of CYP3A4, unless it is suspended> 7 days before inclusion. 12. Any of the following conditions in the 3 months prior to the screening visit: gastrointestinal hemorrhage grade 3 - 4 (unless it is caused by tumor extirpation), peptic ulcer resistant to treatment, esophagitis or erosive gastritis, infectious or inflammatory bowel disease or diverticulitis. 13. Other concomitant or previous malignant neoplasia, except for: i / Carcinoma in situ of the uterine cervix properly treated, ii / spinocellular or basal skin cell carcinoma, iii / cancer in complete remission for> 5 years. 14. Any other non-malignant and uncontrolled serious disease, major surgery or traumatic injury in the last 28 days. 15. Pregnant or during breast-feeding period. 16. Patients with known allergy to any component of the study drugs. 17. History of myocardial infarction and / or stroke in the previous 6 months before inclusion, congestive heart failure NYHA class III and IV. 18. Intestinal obstruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of FOLFIRI + aflibercept in patients with or without ACE polymorphisms in terms of progression-free survival (PFS);Secondary Objective: Objective response rate (ORR) (based on RECIST criteria), disease control rate (DCR), time to progression (TTP), time to treatment failure (TTF) and overall survival (OS) in patients with or without ACE polymorphisms. ORR, DCR, PFS, TTP, TTF and OS in patients with or without polymorphisms AGTR1 and / or according to CEA levels. Safety and tolerability of FOLFIRI + aflibercept.;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: Date of the first disease progression , radiologically observed, or death (event that occurred first) , estimated period: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective response rate (ORR); Disease control rate (DCR); Time to progression (TTP): Time to treatment failure (TFT); Overall survival (OS).;Timepoint(s) of evaluation of this end point: Objective response rate (ORR) during the study treatment period; Disease control rate (DCR) during the study treatment period; Time to progression (TTP): date of the first disease progression or date of the last assessment for patients who died before disease progression; Time to treatment failure (TFT): date of decision to finish study treatment or date of the last disease evaluation for patient who stay on treatment at the end of study. Overall survival (OS): date of death for any reason or last contact date with patient at the end of the study | — |
Countries
Spain
Contacts
Public ContactFátima González Hurtado
Dynamic Science S.L.
Outcome results
None listed