Status:
COMPLETED
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 mCRC After Failure of an Oxaliplatin-based Regimen
Lead Sponsor:
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborating Sponsors:
Sanofi
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is 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 ...
Eligibility Criteria
Inclusion
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically proven adenocarcinoma of the colon and/or rectum,
- Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1
- Patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after a first line oxaliplatin-containing regimen for metastatic disease.
- Age ≥70 years
- World Health Organization (WHO) Performance status (PS) 0-2,
- Hematological status: neutrophils (ANC) ≥1.5x109 /L; platelets ≥100x109 /L; haemoglobin ≥9 g/dL
- Adequate renal function: Creatinine clearance ≥50 mL/min as calculated using the Cockcroft-Gault equation.
- Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alkaline phosphatase (ALP) \<5xULN
- Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour.
- Regular follow-up feasible.
- 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.
Exclusion
- Uncontrolled hypercalcemia,
- Pre-existing permanent neuropathy (NCI grade \>2)
- Uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
- 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,
- 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),
- Patients classified as fragile or delicate according to the following criteria:
- Dependence in one or more activities of daily living according to the Katz Index of Independence in Activities of Daily Living (ADL) scale
- 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
- 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
- Known Gilbert's syndrome
- Intolerance to atropine sulfate or loperamide
- Known dihydropyrimidine dehydrogenase deficiency
- Treatment with CYP3A4 inducers unless discontinued \> 7 days prior to inclusion
- 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.
- Other concomitant or previous malignancy, except: i/ adequately treated insitu carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years,
- Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
- Patients with known allergy to any excipient to study drugs,
- History of myocardial infarction and/or stroke within 6 months prior to inclusion, NYHA class III and IV congestive heart failure
- Bowel obstruction.
- Less than 28 days elapsed from prior radiotherapy
- Patients with pernicious anemia or other megaloblastic anemias due to vitamin B12 deficiency
- Patients with severe infections
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03279289
Start Date
October 25 2017
End Date
February 9 2023
Last Update
April 13 2023
Active Locations (1)
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1
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Madrid, Spain, 28046