- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02624726
Trial in Metastatic Colorectal Cancer With FOLFIRI Plus Aflibercept as First Line Treatment (MINOAS)
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
-
-
Athens, Griekenland
- 251 Air Forces Military Hospital of Athens
-
Athens, Griekenland
- Anicancer Hospital of Athens "Agios Savvas"
-
Athens, Griekenland
- Anticanscer Hospital of Athens "Agios Savvas"
-
Athens, Griekenland
- Athens Hospital "Mitera" Hygia Polis
-
Athens, Griekenland
- General Hospital of Athens "Aretaieio"
-
Athens, Griekenland
- General Hospital of Athens "Sotiria"
-
Athens, Griekenland
- IASO general hospital
-
Río, Griekenland
- University Hospital of Patras-Rio
-
Thessaloniki, Griekenland
- Thessaloniki Bioclinic
-
-
Crete
-
Heraklion, Crete, Griekenland, 71110
- University Hospital of Heraklion Crete
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: FOLFIRI/Aflibercept
5 Fluorouracil/Leucovorin/Irinotecan/Aflibercept
|
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)
Andere namen:
Leucovorin: 400mg/m2, i.v in 2 hours infusion (cycle repeated every two weeks)
Andere namen:
Irinotecan: 180mg/m2, i.v in 90min infusion (cycle repeated every two weeks)
Andere namen:
Aflibercept: 4mg/kg i.v in 1 hour infusion (cycle repeated every two weeks)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Algehele responspercentage
Tijdsspanne: Ziekte-evaluatie in week 8
|
Ziekte-evaluatie in week 8
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Algemeen overleven
Tijdsspanne: 1 jaar
|
1 jaar
|
|
Progressievrije overleving
Tijdsspanne: 1 jaar
|
1 jaar
|
|
Toxicity profile (CTCAE v4.0)
Tijdsspanne: Every 2 weeks up to 100 weeks
|
From date of randomization until the date of last follow up or death from any cause, assessed up to 100 weeks
|
Every 2 weeks up to 100 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: John Souglakos, MD, Hellenic Oncology Research Group
- Hoofdonderzoeker: Athanasios Kotsakis, MD, Hellenic Oncology Research Group
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Colorectale neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Beschermende middelen
- Topoisomeraseremmers
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Micronutriënten
- Vitaminen
- Topoisomerase I-remmers
- Tegengif
- Vitamine B-complex
- Fluoruracil
- Leucovorin
- Irinotecan
- Levoleucovorine
- Aflibercept
Andere studie-ID-nummers
- CT/14.01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Gemetastaseerde colorectale kanker
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
-
BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
-
Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
-
Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Nog niet aan het wervenAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op 5 Fluorouracil
-
The Netherlands Cancer InstituteVoltooid
-
Peking Union Medical College HospitalWervingRectale kanker | Darmkanker | Chemotherapie-effect | PTC | Exon-mutatieChina
-
The Cleveland ClinicNational Cancer Institute (NCI)BeëindigdActinische keratose | Orgaan- of weefseltransplantatie; complicatiesVerenigde Staten
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.OnbekendPlaveiselcelcarcinoom van het hoofd en de halsChina
-
Singapore National Eye CentreSingapore Eye Research Institute; Nanchang UniversityVoltooidGlaucoom | Wond genezen | TrabeculectomieSingapore
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidColorectale kanker | Uitgezaaide kankerVerenigde Staten
-
Encube Ethicals Pvt. Ltd.CBCC Global ResearchVoltooid
-
Hong Kong Nasopharyngeal Cancer Study Group LimitedThe Hong Kong Anti-Cancer Society; hong Kong Cancer FundVoltooid
-
Suzhou Transcenta Therapeutics Co., Ltd.Nog niet aan het wervenMaagkanker | Geavanceerde kanker | Kanker van de gastro-oesofageale overgang