- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01939483
A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES; I. To evaluate the safety and efficacy of irinotecan (irinotecan hydrochloride) in breast cancer patients with brain metastases who progressed after radiation therapy.
II. To estimate central nervous system (CNS) objective response and clinical benefit rate in patients with breast cancer and brain metastases treated with irinotecan.
III. To estimate progression free survival. IV. To estimate overall survival. V. To assess the toxicity of Irinotecan.
OUTLINE:
Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1, 8, 15, 22, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 24 months.
Studietype
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically confirmed diagnosis of breast cancer (irrespective of receptor status), with evidence of CNS disease by computed tomography (CT) or magnetic resonance imaging (MRI), who have progressed after whole brain radiation therapy or stereotactic radiosurgery
- Patients must not be a candidate for surgical resection and/or further stereotactic radiosurgery
- Patients may have had an unlimited number of prior treatments, including any systemic chemotherapy (excluding prior progression of disease with topoisomerase inhibitors as explained below), surgical resection, whole brain radiation, stereotactic radiosurgery, or radioimmunotherapy
- Patient must have MRI of brain obtained within two weeks of study initiation for staging and patients must also receive first dose within two weeks of study enrollment
- Patients must have at least one measurable brain lesion prior to start of treatment (≥ 10 mm on T1-weighted, gadolinium-enhanced MRI)
- Karnofsky performance score greater than 60
- At least two weeks must have elapsed since prior chemotherapy, three weeks must have elapsed since last surgery, and six weeks since completion of radiation therapy
- Hemoglobin > 9
- Absolute neutrophil count (ANC) > 1500
- Platelet count (plt) > 125
- Creatinine < 1.5
- Total bilirubin < 1.5
- Aspartate aminotransferase and alanine aminotransferase levels within five times the upper limit of normal
- Patients may be on oral corticosteroids at stable dose (no dose change within two weeks of enrollment), and may be on antiepileptic medication (except for cytochrome P450 3A4 (CYP3A4) enzyme-inducing antiepileptic medications)
- Fertile patients must use effective contraception
Exclusion Criteria:
- Pregnancy, lactation, immunosuppression other than corticosteroids
- Patient may be on hormonal therapy or Herceptin, but no other concurrent chemotherapy is allowed
- Patients who had progression of their breast cancer after prior administration of irinotecan are excluded
- Patients with leptomeningeal carcinomatosis as the only site of CNS involvement are excluded
- No other active malignancy except for any of the following: curatively treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, other malignancies considered disease-free
- Patients using valproic acid within the last two weeks and patients with contraindications to anticholinergic agents will be excluded
- Concurrent administration of CYP3A4 enzyme-inducing antiepileptic medications (e.g. phenytoin) will not be allowed (if patients are taking one of these agents, they must switch to a non- enzyme-inducing antiepileptic medication prior to start of treatment)
- No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast, and no other known contraindication to MRI
- Homozygous for uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 allele * All patients will be tested for UGT1A genotype prior to starting treatment and be excluded if they are homozygous for the UGT1A1*28 allele (UGT1A1 7/7 genotype); irinotecan's active metabolite glucuronidation of 7-ethyl-10-hydroxycamptothecin (SN-38) is inactivated through glucuronidation by uridine diphosphate glucuronosyltransferases (UGTs) mainly in the liver and is excreted through the bile ducts; a meta-analysis demonstrated that the UGT1A1*28 genotype is moderately predictive of severe irinotecan induced hematologic toxicity at moderate doses and strongly predictive at high doses, and in 2005, the Food and Drug Administration (FDA) added a warning to the irinotecan packaging label that patients with the UGT1A1*28 genotype were at increased risk for neutropenia
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: Treatment (irinotecan hydrochloride)
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1, 8, 15, 22, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. This arm also includes laboratory biomarker analysis as an intervention. |
Correlatieve studies
IV gegeven
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
CNS objective response (complete response or partial response), defined as at least 20% volumetric reduction of CNS lesions in absence of increasing steroid use, progressive neurologic signs and symptoms, or progressive extra-CNS disease, based on MRI
Tijdsspanne: Up to 24 months
|
Up to 24 months
|
Response rate of patients who have remained progression-free, based on MRI
Tijdsspanne: Up to 6 months
|
Up to 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall survival
Tijdsspanne: Time between treatment initiation and death, assessed up to 24 months
|
The product limit estimator developed by Kaplan and Meier was used to graphically describe the distribution of survival among patients with recurrent disease.
|
Time between treatment initiation and death, assessed up to 24 months
|
Progression free survival (PFS)
Tijdsspanne: Time between treatment initiation and disease progression/relapse/death, assessed up to 24 months
|
The product limit estimator developed by Kaplan and Meier was used to graphically describe the distribution of PFS among patients with recurrent disease.
|
Time between treatment initiation and disease progression/relapse/death, assessed up to 24 months
|
Clinical benefit rate (objective response + stable disease at least 16 weeks)
Tijdsspanne: Up to 24 months
|
Up to 24 months
|
|
Frequency of toxicity occurrence, assessed by National Cancer Institute's Common Terminology Criteria (CTC) for Adverse Events version 4.0
Tijdsspanne: Up to 24 months
|
Tabulated by type, and worst grade experienced by the patient.
Toxicity will initially be summarized within each cohort or patient subgroup, and then collectively summarized.
|
Up to 24 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rita Mehta, MD, University of California, Irvine
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Huidziektes
- Neoplasmata
- Neoplasmata per site
- Borst ziekten
- Neoplastische processen
- Borstneoplasmata
- Neoplasma metastase
- Borstneoplasmata, mannelijk
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Antineoplastische middelen, fytogeen
- Topoisomeraseremmers
- Topoisomerase I-remmers
- Irinotecan
- Camptothecine
Andere studie-ID-nummers
- UCI 11-22
- 2011-8497 (Andere identificatie: University of California, Irvine)
- NCI-2013-01136 (Andere identificatie: NCI Clinical Trials Reporting Program (CTRP))
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 Mannelijke borstkanker
-
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
-
Icahn School of Medicine at Mount SinaiNational Institute on Deafness and Other Communication Disorders (NIDCD)VoltooidMal de Debarquement-syndroom (MdDS)Verenigde Staten
-
Icahn School of Medicine at Mount SinaiNew York University; National Institute on Deafness and Other Communication Disorders... en andere medewerkersWervingMal de Débarquement-syndroomVerenigde Staten
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University en andere medewerkersVoltooidDe klinische toepassingsgids van Conebeam Breast CTChina
-
University of MinnesotaVoltooidMal de Debarquement-syndroomVerenigde Staten
-
Mostafa BahaaSahar El-Haggar, Prof Clinical pharmacy Department- Tanta University; Principal... en andere medewerkersWerving
-
University of MinnesotaIngetrokkenMal de Debarquement-syndroom
-
University of MinnesotaIngetrokkenMal de Debarquement-syndroomVerenigde Staten
-
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
Klinische onderzoeken op analyse van biomarkers in het laboratorium
-
Universidad Miguel Hernandez de ElcheInstitut Català de la Salut; Andaluz Health Service; Osakidetza; Servicio Madrileño... en andere medewerkersVoltooidBeroepsziektenSpanje
-
Vanderbilt University Medical Center4DMedicalVoltooid
-
Alcon ResearchVoltooid
-
McGill University Health Centre/Research Institute...Northwestern UniversityWerving
-
St. Antonius HospitalRoche DiagnosticsWervingKwaliteit van het leven | Postoperatieve complicaties | DoodNederland
-
Seoul National University HospitalOnbekendZiekte van Alzheimer | Milde cognitieve stoornisKorea, republiek van
-
University Medical Centre LjubljanaUniversity of LjubljanaActief, niet wervendHartstilstandSlovenië
-
Assiut UniversityNog niet aan het wervenSystemische lupus erythematosus
-
GAP Innovations, PBCVoltooidZiekte van Alzheimer | Milde cognitieve stoornis | Ziekte van Alzheimer, vroeg begin | Geheugenstoornissen | Geheugenstoornis | GeheugenverliesVerenigde Staten
-
Fundacio PuigvertNucleix Ltd.OnbekendUrologische neoplasmata | Urologische kankerSpanje