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Metastatic Colorectal CancerPhase 2MINOASNCT02624726

Trial in Metastatic Colorectal Cancer With FOLFIRI Plus Aflibercept as First Line Treatment

A Phase 2 study testing 5 Fluorouracil, Leucovorin and Irinotecan in people with Metastatic Colorectal Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigators propose to study the combination of m FOLFIRI plus Aflibercept in a Phase II trial of patients with metastatic colorectal cancer. The promising results of aflibercept derived from preclinical studies and from clinical trials conducted in patients with refractory of recurrent to oxaliplatin-based 1st line… 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?
5 Fluorouracil, Leucovorin and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
10 sitesGreece
Study dates
Jan 2016to Mar 2019
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

  • Patients with histologically documented adenocarcinomas of colon or rectum with unresectable metastatic disease.
  • No prior treatment for metastatic disease
  • Metastatic liver disease assessable with diffusion-weighted Magnetic Resonance Imaging (MRI)
  • No previous treatment with bevacizumab or Cetuximab or Panitumumab.
  • Patients may have receive fluoropyrimidines with or without oxaliplatin as adjuvant treatment, if they have progressed > 12 months after the end of the last cycle of the adjuvant treatment
  • Performance Status (ECOG) 0-2
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  • Life expectancy ≥ 3 months.
  • Effective contraception for both male and female subjects if the risk of conception exists.
  • Adequate laboratory parameters: Absolute neutrophils count ≥ 1.5 x 109 /L, Platelets ≥ 100 x 109 /L, Leucocytes > 3,000/mm; Hemoglobin> 10.5g/dl, creatinine clearance ≥ 60 ml/min, Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour, Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal, total Bilirubin ≤ 1.5 times the upper limit of normal; aspartate and alanine aminotransferase ≤ 3 times of the upper normal limit in absence of liver metastases, or ≤5x Upper Normal Limits (UNL) in presence of liver metastases, alkaline phosphatases < 5x UNL
  • All patients will have to sign written informed consent in order to participate in the study.
  • 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

  • Known hypersensitivity reaction to the component of the treatment.
  • Inability to underwent a diffusion-weighted MR Imaging at baseline and in predefined time points
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  • History or evidence upon physical examination of Central Nervous System (CNS) metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
  • 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.
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  • Other serious and uncontrolled non-malignant disease
  • Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy.
  • Gilbert's syndrome
  • Intolerance to atropine sulfate or loperamide
  • Known dihydropyrimidine dehydrogenase deficiency
  • Treatment with 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
  • Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days
  • INR in absence of anticoagulation therapy > 1.25 or poorly controlled anti-coagulation therapy on coumadin or heparin compounds (INR >3.0)
  • History of myocardial infarction and/or stroke within 6 months prior to randomization, New York Heart Association (NYHA) class III and IV congestive heart failure
  • History of life threatening (grade 4) venous thromboembolic events (including pulmonary embolism) within 6 months prior to registration,
  • Bowel obstruction
  • Legal incapacity or limited legal capacity.
  • Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent.
  • A second primary tumour other than non-melanoma skin cancer or in situ cervical cancer.
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on chest CT scan.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Greece10 sites

  • 251 Air Forces Military Hospital of Athens

    Athens

  • Anicancer Hospital of Athens "Agios Savvas"

    Athens

  • Anticanscer Hospital of Athens "Agios Savvas"

    Athens

  • Athens Hospital "Mitera" Hygia Polis

    Athens

  • General Hospital of Athens "Aretaieio"

    Athens

  • General Hospital of Athens "Sotiria"

    Athens

  • IASO General Hospital

    Athens

  • University Hospital of Heraklion Crete

    Heraklion, Crete, 71110

  • University Hospital of Patras-Rio

    Rio

  • Thessaloniki Bioclinic

    Thessaloniki

Other trials in Greece

About this study

Official title: A Open Label, Non Randomized, Phase Two Trial in Metastatic Colorectal Cancer (mCRC) With the Combination of m FOLFIRI Plus Aflibercept as First Line Treatment: MINOAS Trial

Investigators propose to study the combination of m FOLFIRI plus Aflibercept in a Phase II trial of patients with metastatic colorectal cancer. The promising results of aflibercept derived from preclinical studies and from clinical trials conducted in patients with refractory of recurrent to oxaliplatin-based 1st line treatment in patients with mCRC open the field to explore such therapeutic approaches in the 1st line setting in combination with the FOLFIRI regimen.

Read the detailed description

Colorectal cancer accounts for 8% of all malignant tumors in adults and is considered as a major cause of cancer morbidity and mortality worldwide. Although curative surgical resection is possible in 70-80% of patients at diagnosis, almost half of them will develop local or/and metastatic recurrence and will die of the disease with the liver been the most common site of metastatic spread from CRC.

Combinations of infusional administrated 5-fluorouracil/Leucovorin with irinotecan or oxaliplatin are accepted as the mainstay of first-line treatment and have increase the median overall survival of patients with advanced CRC from 12 months to about 21-22 months. In addition, resection for colorectal metastases (mainly in the liver), has become the standard of care, for patients with limited metastatic disease confounded to the liver and currently remains the only potentially curative therapy Aflibercept, also known as vascular endothelial growth factor (VEGF) Trap, is an angiogenesis inhibitor with a unique mechanism of action. Aflibercept is a recombinant fusion protein that consists of portions of human VEGFR1 and VEGFR2 extracellular domains fused to the Fc portion of human immunoglobulin G1. This fusion protein binds all forms of Vascular Endothelial Growth Factor-A, as well as VEGF-B and placental growth factor, additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. Aflibercept has been shown to bind VEGF-A, VEGF-B, and placental growth factor (PlGF) with higher affinity than their native receptors. In vitro and in vivo studies have shown that aflibercept can inhibit new vessel growth and tumor vascularization in tumor models.

Being tested
5 Fluorouracil, Leucovorin, Irinotecan, Aflibercept
Keywords
1st line, FOLFIRI, Aflibercept, mCRC
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5 FluorouracilDrug

    Also called 5 Fluorouracil (5-FU)

    5 Fluorouracil: 400mg/m2, bolus infusion in <5min followed by 5 Fluorouracil: 2400mg/m2, i.v in 46 hours continuous infusion (cycle repeated every two weeks)

  • LeucovorinDrug

    Also called Leucovorin (LV)

    Leucovorin: 400mg/m2, i.v in 2 hours infusion (cycle repeated every two weeks)

  • IrinotecanDrug

    Also called Irinotecan (CPT-11)

    Irinotecan: 180mg/m2, i.v in 90min infusion (cycle repeated every two weeks)

  • AfliberceptDrug

    Also called Zaltrap

    Aflibercept: 4mg/kg i.v in 1 hour infusion (cycle repeated every two weeks)

Study groups in NCT02624726
Study groupRoleWhat they receive
FOLFIRI/AfliberceptExperimental5 Fluorouracil/Leucovorin/Irinotecan/Aflibercept
Receives: Drug: 5 Fluorouracil; Drug: Leucovorin; Drug: Irinotecan; Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Measured: Disease evaluation at Week 8

Secondary outcomes (3)

  1. Progression Free Survival

    Measured: 1 year

  2. Overall Survival

    Measured: 1 year

  3. Toxicity profile (CTCAE v4.0)

    From date of randomization until the date of last follow up or death from any cause, assessed up to 100 weeks

    Measured: Every 2 weeks up to 100 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionOct 2018
  4. Study completionMar 2019 (estimated)

Resources

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02624726
Sponsor's protocol ID
CT/14.01
Acronym
MINOAS
Status last verified
Jan 2019
First submitted
24 Nov 2015
Last updated
22 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Matikas A, Souglakos J, Katsaounis P, Kotsakis A, Kouroupakis P, Pantazopoulos N, Kentepozidis N, Nikolaidi A, Messaritakis I, Tzovara I, Hatzidaki D, Prinarakis E, Georgoulias V. MINOAS: A Single-arm Translational Phase II Trial of FOLFIRI Plus Aflibercept as First-line Therapy in Unresectable, Metastatic Colorectal Cancer. Target Oncol. 2019 Jun;14(3):285-293. doi: 10.1007/s11523-019-00647-3.

    PubMed 31203498

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5 Fluorouracil, Leucovorin and Irinotecan in people with Metastatic Colorectal Cancer, run by Hellenic Oncology Research Group at 10 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 11 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Results are not available in the source record.

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?

Overall Response Rate (time frame: Disease evaluation at Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02624726, which also lists 1 linked publication.

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 22 Feb 2019.

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