Clinical trial · Interventional
Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer
Single-arm Phase II Study of Maintenance Therapy With Aflibercept After First-line Treatment With FOLFIRI Plus Aflibercept in Metastatic Colorectal Cancer Patients
NCT02129257CI-TRIAL-00030023AMALTHEAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The AMALTHEA (Aflibercept MAintenance after first-Line THErapy with FOLFIRI+Aflibercept in metastatic colorectal cancer patients) trial is an investigator-initiated, single arm, open-label, phase II study. Patients with histologically proven metastatic colorectal carcinoma will be treated with a combination of FOLFIRI and aflibercept for 6 months. Both Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) and mutant (mut) patients wil be enrolled. In the absence of Progressive Disease (PD) after 6 months of the combination of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with aflibercept alone until PD or unacceptable toxicity, investigator's decision or patient's refusal of further treatment or death, whichever comes first.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| AFLIBERCEPT | Drug | Aflibercept | ALIAS |
| Folinic Acid | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRI-AFLIBERCEPT
- description
- Aflibercept 4 mg/kg administered over 1 hour on Day 1, followed by FOLFIRI regimen. Treatment will be repeated every 2 weeks. FOLFIRI regimen: Irinotecan 180 mg/m² intravenous (IV) infusion and folinic acid 400 mg/m² IV infusion followed by: 5-fluorouracil (5-FU) 400 mg/m² IV bolus followed by: 5-FU 2400 mg/m² continuous IV infusion over 46 hours. FOLFIRI administration will immediately follow the aflibercept one. In the absence of PD after 6 months of the combination of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with aflibercept alone until PD or unacceptable toxicities, investigator's decision or patient's refusal of further treatment or death, whichever comes first.
- interventionNames
- Drug: AFLIBERCEPT
- Drug: Irinotecan
- Drug: 5-Fluorouracil
- Drug: Folinic Acid
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) rate at 1 year
- timeFrame
- Up to 1 year
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologically proven adenocarcinoma of the colon and/or rectum * Metastatic disease confirmed clinically/radiologically * Signed written informed consent * No prior therapy for metastatic disease * Duly documented inoperable metastatic disease, ie not suitable for complete curative surgical resection * At least one measurable or evaluable lesion as assessed by Computed Tomography (CT) scan or MRI (Magnetic Resonance Imaging) according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2 * Adequate hematological status: * neutrophils (ANC) ≥1.5x109/L * platelets ≥100x109/L * haemoglobin ≥9g/dL * Adequate renal function: serum creatinine level \<1.5 mg/dl and Glomerular Filtration Rate\>50 ml/min by Cockroft/Gault formula * Adequate liver function: * serum bilirubin ≤1.5 x upper normal limit (ULN) * alkaline phosphatase * aspartate aminotransferase (AST) * alanine aminotransferase (ALT) \< 5 x ULN * Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour * Regular follow-up feasible * Baseline evaluations performed before registration: clinical and blood evaluations no more than 2 weeks (14 days) prior to registration, tumor assessment (chest X-ray, CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to registration * First course of treatment planned less than 1 week (7 days) after registration * For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior of starting study treatment * Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). 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 Criteria * Exclusive presence of bone metastasis only * Uncontrolled hypercalcemia * Uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg despite medical therapy), or history of hypertensive crisis, or hypertensive encephalopathy * Concomitant 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 chronic disease * History or presence of Central Nervous System (CNS) metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizures not controlled with standard medical therapy) * Gilbert's syndrome * Intolerance to atropine sulfate or loperamide * Known dihydropyrimidine dehydrogenase deficiency * Treatment with Cytochrome P450 3A4 (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 * Other concomitant or previous malignancy, except: * adequately treated in-situ carcinoma of the uterine cervix * basal or squamous cell carcinoma of the skin * 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 * Pregnant or breastfeeding women * Patients with known allergy to any excipients to study drugs * History of myocardial infarction and/or stroke or other arterial thrombotic events or pulmonary embolism or unstable angina pectoris within 6 months prior to registration * Poorly controlled cardiac arrhythmias * Bowel obstruction * History of severe tumour bleeding or bleeding disorders * Poorly controlled anti-coagulation therapy (INR\>3.0 on coumadin or heparin compounds) * Palliative radiation therapy within 4 weeks prior to registration
References
Publications (0)
Data not yet available
No reference posted for this study.