Metastatic Colorectal CancerPhase 2AMALTHEANCT02129257
Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer
A Phase 2 study testing AFLIBERCEPT, Irinotecan and 5-Fluorouracil in people with Metastatic Colorectal Cancer, run by Hellenic Cooperative Oncology Group at 18 sites in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- AFLIBERCEPT, Irinotecan and 5-Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 18 sitesGreece
- Study dates
- 26 May 2014to 25 Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Greece18 sites
2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital
Athens, 11522
251 Airforce Hospital
Athens, 11525
2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio"
Athens, 11527
Oncology Unit, 3rd Dept of Internal Medicine, Athens School of Medicine, Sotiria General Hospital
Athens, 11527
Oncology Section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"
Athens, 11528
Division of Oncology, 2nd Dept of Internal Medicine, University Hospital "Attiko"
Athens, 12462
2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, 14564
3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital
Athens, 14564
3rd Dept of Medical Oncology, Hygeia Hospital
Athens, 15123
1st Dept of Medical Oncology, Metropolitan Hospital
Athens, 18547
2nd Dept of Medical Oncology, Metropolitan Hospital
Athens, 18547
Agios Georgios Chania General Hospital
Chania, Mournies, 73300
Dept of Medical Oncology, University Hospital of Heraklion
Heraklio, 71110
Dept of Medical Oncology, Ioannina University Hospital
Ioannina, 45500
Oncology Dept, University Hospital of Larissa
Larissa, 41334
Division of Oncology, Dept of Internal Medicine, University Hospital of Patras
Pátrai
Thermi Clinic S.A.
Thermi, 57001
Dept of Medical Oncology, Papageorgiou General Hospital
Thessaloniki, 56429
About this study
Official title: Single-arm Phase II Study of Maintenance Therapy With Aflibercept After First-line Treatment With FOLFIRI Plus Aflibercept in Metastatic Colorectal Cancer Patients
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.
Read the detailed description
Statistical hypotheses and sample size calculation:
It is estimated that the progression-free survival (PFS) rate at 1year will be improved from 33% (corresponding to a median PFS of 7.5 months [null hypothesis]) to 47% (corresponding to a median PFS of 11 months [alternative hypothesis]) with the combination of first-line Folinic acid/5-Fluorouracil/Irinotecan (FOLFIRI) plus aflibercept therapy in patients with metastatic colorectal cancer (mCRC). Using the one-stage Fleming's design, in order to reject the null hypothesis in a one-sided test with a type I error of 5% and power 80%, 73 patients will be needed to enter the study.
Analysis population:
- Intent-to-treat (ITT) population: all patients who will have given their informed consent and who will have been correctly registered to the study
- Evaluable population for tumor response: all treated patients, without major protocol deviation, with at least one tumor evaluation while on treatment (except for early disease progression or death) and evaluable for response
- Safety population: the subset of the ITT population that took at least one dose of study medication
Primary analysis:
The primary efficacy parameter will be PFS rate at 1 year and it will be calculated in the ITT population.
Analysis of secondary endpoints:
Response to treatment will be described in a frequency table along with the corresponding percentages and 95% exact confidence intervals.
Kaplan-Meier method will be used to estimate median PFS and overall survival (OS) values and 95% confidence intervals. All of these analyses will be performed in the ITT population. Analysis for objective response rate (ORR) will additionally be presented in the evaluable population for tumor response.
Adverse Events (AEs) of the safety population for the FOLFIRI-aflibercept treatment part and the maintenance therapy will be presented in frequency tables according to grade, along with the corresponding percentages (N, %).
Exploratory endpoints:
Univariate and multivariate Cox regression analyses will also be performed to explore prognostic factors among basic clinicopathological characteristics and evaluated biomarkers, with respect to PFS and OS. Time-to-event distributions for the expression of examined markers will be estimated by Kaplan-Meier method and compared using log-rank test.
Formalin-fixed embedded tumor tissue blocks will be collected from the primaries or metastases for the immunohistochemical and messenger ribonucleic acid (mRNA) study of key angiogenic effectors and regulators, such as: vascular endothelial growth factor A (VEGF A), vascular endothelial growth factor A-121 (VEGFA-121), vascular endothelial growth factor A121b (VEGFA121b), short and long VEGFA isoforms, metalloproteinase inhibitor 3 (TIMP3), vascular endothelial growth factor B (VEGF-B), placental growth factor (PlGF), vascular endothelial growth factor-C (AVEGF-C), Semaphorins, hypoxia-inducible factor 1 (HIF1), vascular endothelial growth factor receptor 1 (VEGFR1), vascular endothelial growth factor receptor 2 (VEGFR2), neuropilin 1 (NRP1), neuropilin 2 (NRP2), thrombospondin 1 (TSP1), thrombospondin 2 (TSP2), angiopoietin-1 (Ang1), Angiopoietin-2 (Ang2), Tie2, interleukin 8 (IL8), CXC chemokine receptor 1 (CXCR1), CXC chemokine receptor 2 (CXCR2)
Pharmacokinetic(PK)/Pharmacodynamic analyses (PD) PK/PD assessments (plasma analytes, plasma free and VEGF-bound aflibercept) will be performed in all registered and treated patients at specified timepoints during both FOLFIRI-aflibercept induction and aflibercept maintenance therapy, to assess the free/bound aflibercept ratio over cycles and the potential correlation with clinical endpoints (safety and efficacy).
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- AFLIBERCEPT, Irinotecan, 5-Fluorouracil, Folinic Acid
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFLIBERCEPTDrug
Also called Zaltrap, AVE005
IrinotecanDrug
Also called Campto
5-FluorouracilDrug
Folinic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI-AFLIBERCEPT | Experimental | 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. Receives: Drug: AFLIBERCEPT; Drug: Irinotecan; Drug: 5-Fluorouracil; Drug: Folinic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) rate at 1 year
Measured: Up to 1 year
Secondary outcomes (7)
Evaluation of Objective Response Rate (ORR) defined as the proportion of patients with complete response (CR) or partial response (PR) among all patients, as assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Response to treatment will be described in a frequency table along with the corresponding percentages and 95% exact confidence intervals.
Measured: Up to 20 months
Evaluation of Overall Survival (OS)
Measured: Time interval from registration to the date of death due to any cause assessed up to 60 months
Evaluation of Progression-Free Survival (PFS)
Measured: Time interval from registration to the first date of documented progression or death due to any cause assessed up to 60 months
Number of participants with Serious and Non-Serious Adverse Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Adverse Events of the safety population for the FOLFIRI-aflibercept treatment part and the maintenance therapy will be presented in frequency tables according to grade, along with the corresponding percentages (N,%)
Measured: Up to 40 months
Tumor tissue mRNA levels of VEGFA-121, VEGFA121b, VEGF-B, PlGF, VEGF-C, Semaphorins, HIF1, VEGFR1, VEGFR2, Neuropilins 1,2, Thrombospondin, Angiopoietins 1,2. Predictive significance for response rate, PFS, OS.
Measured: Tumor blocks will be collected at baseline
Steady-state concentration of free Aflibercept and VEGF-bound Aflibercept in plasma. Predictive significance for response rate, PFS, OS.
Measured: On day 1 of cycle 1, on day 1 of cycle 3, on day 1 of week 3 of Aflibercept maintenance monotherapy, at the end of treatment, assessed up to 20 months
Enzyme-linked immunosorbent assay (ELISA) plasma concentrations of VEGFA, soluble VEGFR1, soluble VEGFR2, VEGF-B, PlGF, basic fibroblast growth factor (bFGF), hepatocyte growth factor (HGF). Predictive significance for response rate, PFS, OS.
Measured: On day 1 of cycle 1, on day 1 of cycle 3, on day 1 of week 3 of Aflibercept maintenance monotherapy, at the end of treatment, assessed up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start26 May 2014
- Primary completionJan 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- George Pentheroudakis, MD, Ass.Prof, Study chair, Dept of Medical Oncology, Ioannina University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129257
- Sponsor's protocol ID
- HE 6A/13
- Other IDs
- 2013-002567-26
- Acronym
- AMALTHEA
- Status last verified
- Oct 2017
- First submitted
- 28 Apr 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Phase II Study of Maintenance Therapy With Aflibercept After First-line Treatment With FOLFIRI Plus Aflibercept in Metastatic Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT02129257
- Acronym / sponsor ID
- AMALTHEA / HE 6A/13
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 26 May 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Statistical hypotheses and sample size calculation:
It is estimated that the progression-free survival (PFS) rate at 1year will be improved from 33% (corresponding to a median PFS of 7.5 months [null hypothesis]) to 47% (corresponding to a median PFS of 11 months [alternative hypothesis]) with the combination of first-line Folinic acid/5-Fluorouracil/Irinotecan (FOLFIRI) plus aflibercept therapy in patients with metastatic colorectal cancer (mCRC). Using the one-stage Fleming's design, in order to reject the null hypothesis in a one-sided test with a type I error of 5% and power 80%, 73 patients will be needed to enter the study.
Analysis population:
- Intent-to-treat (ITT) population: all patients who will have given their informed consent and who will have been correctly registered to the study
- Evaluable population for tumor response: all treated patients, without major protocol deviation, with at least one tumor evaluation while on treatment (except for early disease progression or death) and evaluable for response
- Safety population: the subset of the ITT population that took at least one dose of study medication
Primary analysis:
The primary efficacy parameter will be PFS rate at 1 year and it will be calculated in the ITT population.
Analysis of secondary endpoints:
Response to treatment will be described in a frequency table along with the corresponding percentages and 95% exact confidence intervals.
Kaplan-Meier method will be used to estimate median PFS and overall survival (OS) values and 95% confidence intervals. All of these analyses will be performed in the ITT population. Analysis for objective response rate (ORR) will additionally be presented in the evaluable population for tumor response.
Adverse Events (AEs) of the safety population for the FOLFIRI-aflibercept treatment part and the maintenance therapy will be presented in frequency tables according to grade, along with the corresponding percentages (N, %).
Exploratory endpoints:
Univariate and multivariate Cox regression analyses will also be performed to explore prognostic factors among basic clinicopathological characteristics and evaluated biomarkers, with respect to PFS and OS. Time-to-event distributions for the expression of examined markers will be estimated by Kaplan-Meier method and compared using log-rank test.
Formalin-fixed embedded tumor tissue blocks will be collected from the primaries or metastases for the immunohistochemical and messenger ribonucleic acid (mRNA) study of key angiogenic effectors and regulators, such as: vascular endothelial growth factor A (VEGF A), vascular endothelial growth factor A-121 (VEGFA-121), vascular endothelial growth factor A121b (VEGFA121b), short and long VEGFA isoforms, metalloproteinase inhibitor 3 (TIMP3), vascular endothelial growth factor B (VEGF-B), placental growth factor (PlGF), vascular endothelial growth factor-C (AVEGF-C), Semaphorins, hypoxia-inducible factor 1 (HIF1), vascular endothelial growth factor receptor 1 (VEGFR1), vascular endothelial growth factor receptor 2 (VEGFR2), neuropilin 1 (NRP1), neuropilin 2 (NRP2), thrombospondin 1 (TSP1), thrombospondin 2 (TSP2), angiopoietin-1 (Ang1), Angiopoietin-2 (Ang2), Tie2, interleukin 8 (IL8), CXC chemokine receptor 1 (CXCR1), CXC chemokine receptor 2 (CXCR2)
Pharmacokinetic(PK)/Pharmacodynamic analyses (PD) PK/PD assessments (plasma analytes, plasma free and VEGF-bound aflibercept) will be performed in all registered and treated patients at specified timepoints during both FOLFIRI-aflibercept induction and aflibercept maintenance therapy, to assess the free/bound aflibercept ratio over cycles and the potential correlation with clinical endpoints (safety and efficacy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI-AFLIBERCEPT | Experimental | Drug: AFLIBERCEPT, Drug: Irinotecan, Drug: 5-Fluorouracil, Drug: Folinic AcidAflibercept 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFLIBERCEPTAlso: Zaltrap, AVE005 | Drug | FOLFIRI-AFLIBERCEPT |
| IrinotecanAlso: Campto | Drug | FOLFIRI-AFLIBERCEPT |
| 5-Fluorouracil | Drug | FOLFIRI-AFLIBERCEPT |
| Folinic Acid | Drug | FOLFIRI-AFLIBERCEPT |
Primary outcome
Progression-Free Survival (PFS) rate at 1 year
Time frame: Up to 1 year
7 secondary outcomes
Evaluation of Objective Response Rate (ORR) defined as the proportion of patients with complete response (CR) or partial response (PR) among all patients, as assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Time frame: Up to 20 months
Evaluation of Overall Survival (OS)
Time frame: Time interval from registration to the date of death due to any cause assessed up to 60 months
Evaluation of Progression-Free Survival (PFS)
Time frame: Time interval from registration to the first date of documented progression or death due to any cause assessed up to 60 months
Number of participants with Serious and Non-Serious Adverse Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Time frame: Up to 40 months
Tumor tissue mRNA levels of VEGFA-121, VEGFA121b, VEGF-B, PlGF, VEGF-C, Semaphorins, HIF1, VEGFR1, VEGFR2, Neuropilins 1,2, Thrombospondin, Angiopoietins 1,2. Predictive significance for response rate, PFS, OS.
Time frame: Tumor blocks will be collected at baseline
Steady-state concentration of free Aflibercept and VEGF-bound Aflibercept in plasma. Predictive significance for response rate, PFS, OS.
Time frame: On day 1 of cycle 1, on day 1 of cycle 3, on day 1 of week 3 of Aflibercept maintenance monotherapy, at the end of treatment, assessed up to 20 months
Enzyme-linked immunosorbent assay (ELISA) plasma concentrations of VEGFA, soluble VEGFR1, soluble VEGFR2, VEGF-B, PlGF, basic fibroblast growth factor (bFGF), hepatocyte growth factor (HGF). Predictive significance for response rate, PFS, OS.
Time frame: On day 1 of cycle 1, on day 1 of cycle 3, on day 1 of week 3 of Aflibercept maintenance monotherapy, at the end of treatment, assessed up to 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Pentheroudakis, MD, Ass.Prof study chair
Dept of Medical Oncology, Ioannina University Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFLIBERCEPT, Irinotecan and 5-Fluorouracil in people with Metastatic Colorectal Cancer, run by Hellenic Cooperative Oncology Group at 18 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) rate at 1 year (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.