EUCTR2016-004076-21-ESActive, not recruitingPhase 1
Randomised, multicentre, phase II pilot study to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen - AFEMA
Grupo de Tratamiento de los Tumores Digestivos (TTD)0 sitesStarted: May 29, 2017Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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 < 1.5 x ULN
- •9. Adequate liver function: serum bilirubin =1.5 x upper normal limit (ULN), alkaline phosphatase (ALP) <5xULN
- •10. Proteinuria <2+ (dipstick urinalysis) or =1g/24hour.
- •11. Regular follow-up feasible.
- •12. Male patients with a partner of childbearing potential must agree to use
- •contraception in addition to having their partner use another contraceptive
- •method during the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
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
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