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- Klinische proef NCT01093092
Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery
A Phase I Clinical Trial of Oral Calcitriol With Fixed Dose of Cisplatin and Gemcitabine in Patients With Advanced Solid Tumors
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of oral calcitriol when combined with a standard dose of gemcitabine (gemcitabine hydrochloride) and cisplatin in a 28-day cycle.
SECONDARY OBJECTIVES:
I. Describe the toxicity of this combination using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. Study the pharmacokinetics of calcitriol at the maximum tolerated dose (MTD) in an expanded cohort of 6 patients.
III. Describe the clinical activity associated with this regimen in this advanced solid tumor population.
OUTLINE:
Patients receive calcitriol orally (PO) on days 1, 2, 8, 9, 15 and 16; cisplatin intravenously (IV) over 2 hours on day 2; and gemcitabine hydrochloride IV over 30 minutes on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New York
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Buffalo, New York, Verenigde Staten, 14263
- Roswell Park Cancer Institute
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22903
- Emily Couric Clinical Cancer Center
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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 a diagnosis of advanced unresectable non-hematological malignancy that has no known standard of care or for which the use of gemcitabine plus cisplatin constitutes a reasonable option
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- White blood cell (WBC) >= 3.0 x 10^9/L
- Neutrophils >= 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Hemoglobin (Hgb) >= 10 g/dL
- Bilirubin =< institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x institutional ULN unless metastatic to liver in which case AST and ALT should be < 5 x institutional ULN
- Creatinine =< 1.5 x institutional ULN
- Corrected calcium =< institutional ULN (corrected calcium = (4- Albumin) x 0.8 + calcium)
- Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- No treatment with investigational agents within 4 weeks prior to study drug administration, except patients receiving targeted therapies such as kinase inhibitors with half-lives < 48 hours may be treated if > 14 days have elapsed after the last dose and related toxicities have recovered to =< grade 1
- No chemotherapy within 4 weeks prior to study treatment administration; nitrosoureas and mitomycin C are not allowed within 6 weeks prior to initiation of study treatment
- Palliative radiation, including whole brain radiation therapy (WBRT), is allowed prior to enrollment as long as it is completed > 2 weeks from initiation of study treatment, and provided patient has recovered from treatment toxicities to =< grade 1
- Patients should be able to take oral medications
Exclusion Criteria:
- Known hypersensitivity to any of the study drugs involved
- Brain metastases are excluded unless treated and shown to be controlled more than 1 month from after craniotomy or more than 2 weeks after gamma knife radiosurgery and not associated with central nervous system (CNS) symptoms
- History of clinically significant hypercalcemia
- Evidence of nephrectomy
- History of (within 24 months prior to enrollment) of kidney, ureter, or bladder stones with clinically significant sequelae (e.g. (painless gross hematuria; pain with or without infection; hydronephrosis, etc); patients with otherwise stable non-occluding kidney stones regardless of stone type incidentally found in computed tomography (CT) scans are eligible; patients with prior history of uric acid stones are eligible regardless of time of onset
- Unwillingness to stop calcium supplementation (during the first cycle of treatment) or vitamin D supplementation throughout the study
- Thiazide (e.g HCTZ, Hydrochoirthiazide) or digoxin therapy (e.g Lanoxicaps, Lanoxin)
- Pregnant or nursing female patients.
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
- Received an investigational agent within 4 weeks prior to enrollment, except patients receiving targeted therapies such as kinase inhibitors with half-lives < 48 hours may be treated if > 14 days have elapsed after the last dose and related toxicities have recovered to =< grade 1
- Nut allergy
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 (calcitriol, cisplatin, gemcitabine hydrochloride)
Patients receive calcitriol PO on days 1, 2, 8, 9, 15 and 16; cisplatin IV over 2 hours on day 2; and gemcitabine hydrochloride IV over 30 minutes on days 2, 9, and 16.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Correlatieve studies
Andere namen:
IV gegeven
IV gegeven
Andere namen:
Gegeven PO
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
MTD of oral calcitriol when combined with a standard dose of gemcitabine hydrochloride and cisplatin, determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0
Tijdsspanne: 28 days
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A standard 3+3 with de-escalation will be used to estimate the MTD.
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28 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Toxicity of this combination, graded according to NCI CTCAE version 4.0
Tijdsspanne: Up to 30 days after last dose of study drug
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Tabulated overall or by dose level (as appropriate).
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Up to 30 days after last dose of study drug
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Pharmacokinetic (PK) analyses of calcitriol at the MTD in an expanded cohort of 6 patients, including peak levels, area under the concentration-time curve from time 0-72 hours, terminal half-life, volume of distribution, and total body clearance
Tijdsspanne: Days 1-3 of course 1
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PK data will be presented as plots of serum calcitriol concentration over time for each patient.
An assessment of whether systemic calcitriol exposure associated with antitumor activity in preclinical models is achieved in these patients will be made.
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Days 1-3 of course 1
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Objective tumor response, described using Response Evaluation Criteria in Solid Tumors 1.1
Tijdsspanne: Up to 5 years
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Responses tabulated as appropriate.
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Up to 5 years
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Grace Dy, Roswell Park Cancer Institute
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
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
Aanvullende relevante MeSH-voorwaarden
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Micronutriënten
- Membraantransportmodulatoren
- Vitaminen
- Behoudsmiddelen voor botdichtheid
- Calciumregulerende hormonen en middelen
- Vasoconstrictieve middelen
- Calciumkanaalagonisten
- Gemcitabine
- Calcitriol
- Dihydroxycholecalciferolen
Andere studie-ID-nummers
- I 163509 (Andere identificatie: Roswell Park Cancer Institute)
- P30CA016056 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2010-00263 (Register-ID: CTRP (Clinical Trial Reporting Program))
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 .
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