Metastatic colorectal cancer MedDRA version: 20.0 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
Trade Name: 5 Fluorouracilo
Product Name: 5 Fluorouracilo
Product Code: 71.868
Pharmaceutical Form: Concentrate for solu
Sponsors
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent, and willing and able to comply with protocol requirements, 2. Histologically proven adenocarcinoma of the colon and/or rectum, 3. Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1 4. Patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after a first line oxaliplatin-containing regimen for metastatic disease. 5. Age =70 years 6. World Health Organization (WHO) Performance status (PS) 0-2, 7. Hematological status: neutrophils (ANC) =1.5x109/L; platelets =100x109/L; haemoglobin =9g/dL 8. Adequate renal function: serum creatinine level =65 years) yes F.1.3.1 Number of subjects for this age range 168
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypercalcemia, 2. Pre-existing permanent neuropathy (NCI grade >2) 3. Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy, 4. Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), 5. Treatment with any other investigational medicinal product within 28 days prior to study entry. 6. Other serious and uncontrolled non-malignant disease, 7. 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), 8. Patients classified as fragile or delicate according to the following criteria: a. Dependence in one or more activities of daily living according to the Katz Index of Independence in Activities of Daily Living (ADL) scale (Appendix 8) b. Three or more comorbidities when assessing the presence of the following processes: congestive heart failure; heart valve disease; coronary artery disease; chronic (obstructive or restrictive) pulmonary disease; cerebrovascular disease; peripheral neuropathy, chronic kidney failure; hypertension; diabetes; concomitant cancers; collagen vascular disease; chronic liver disease; and disabling arthritis c. Presence of geriatric syndromes: moderate-severe dementia; delirium in stressful situations (urinary or respiratory tract infection, angina or drugs); moderate-severe depression that interferes with the patient’s usual activity; frequent falls (three or more per month); inattentiveness (who could help you in the event of an emergency?); urinary incontinence in the absence of stress, infection, diuretics or prostatic hyperplasia; faecal incontinence in the absence of diarrhoea or laxatives; osteoporotic fractures of large bones or vertebral compression fractures 9. Known Gilbert’s syndrome 10. Intolerance to atropine sulfate or loperamide 11. Known dihydropyrimidine dehydrogenase deficiency 12. Treatment with CYP3A4 inducers unless discontinued > 7 days prior to inclusion 13. 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. 14. Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/cancer in complete remission for >5 years, 15. Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days 16. Patients with known allergy to any excipient to study drugs, 17. History of myocardial infarction and/or stroke within 6 months prior to inclusion, NYHA class III and IV congestive heart failure 18. Bowel obstruction. 19. Less than 28 days elapsed from prior radiotherapy 20. Patients with pernicious anemia or other megaloblastic anemias due to vitamin B12 deficiency 21. Patients with severe infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the non inferiority of aflibercept + 5FU/LV as maintenance vs aflibercept + FOLFIRI with progression free survival (PFS) as the primary outcome parameter in elderly patients (=70 years).;Secondary Objective: 1. Objective Response Rate (ORR) (based on the RECIST criteria), Disease Control Rate (DCR), Depth of response (DpR), Time to progression (TP), Time to treatment failure (TTF) and Overall survival (OS) 2. Safety and tolerability 3. VES-13 score (Vulnerable Elders Survey) as the utility measure for health deterioration;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: Date of the frist disease progression radiologically observed or death (even than occurred first) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Efficacy: 1.a. Objective response rate based on the RECIST criteria 1.b. Disease control rate 1.c. Depth of response 1.d. Time to progression 1.e. Time to treatment failure 1.f. Overall survival 2. Safety: 2.a. Incidence and severity of AEs CTCAE v4.03 criteria. 2.b. Incidence of dose adjustments and compliance 3. Health deterioration;Timepoint(s) of evaluation of this end point: Objective response rate, Disease control rate, Depth of response, Incidence and severity of AEs, Incidence of dose adjustments and compliance, Health deterioration: during the study treatment period Time to progression: date of the first disease progression. Time to treatment failure: date od 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: date of death for any reason or last contact date with patient at the end of the study | — |
Countries
Spain
Contacts
Public ContactMamen Jiménez Aranda
Dynamic S.L.
Outcome results
None listed