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- Klinische proef NCT00238394
Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer
A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. Determine the 6-month survival of patients with locally advanced or metastatic hepatocellular carcinoma treated with AZD2171.
SECONDARY OBJECTIVES I. Determine tumor response and time to progression in patients treated with this drug.
II. Determine the toxicity of this drug in these patients. III. Correlate biological markers with response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 20-44 patients will be accrued for this study within 22 months.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- North Central Cancer Treatment Group
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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:
Histologically confirmed hepatocellular carcinoma
- Locally advanced or metastatic disease
- Not amenable to treatment with surgery or orthotopic liver transplantation
Measurable or non-measurable disease
- Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Evidence of disease progression by imaging on serial exams or biochemical evidence of a rising alpha fetoprotein on serial testing
No history of brain metastases other than locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery)
- Patients with locally treatable CNS disease eligible provided they were previously treated and had no evidence of CNS progression for ≥ 4 weeks after completion of treatment
- No fibrolamellar hepatocellular carcinoma or mixed cholangiocarcinoma/hepatocellular carcinoma
- Performance status - ECOG 0-1
- Absolute neutrophil count ≥ 1,200/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- AST ≤ 5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Urine protein < 1+ by urine dip stick OR proteinuria < 1 gm/24-hour collection
- QTc prolongation ≤ 500 msec
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No uncontrolled blood pressure, defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg
- No significant ECG abnormality within the past 14 days
- No New York Heart Association class III or IV disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No history of allergic reaction to compounds of similar chemical or biological composition to AZD2171
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study participation
- No other uncontrolled illness
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior and no concurrent immunotherapy
- No colony-stimulating factors during the first course of study treatment
At least 6 weeks since prior chemoembolization
- Patients must have evidence of disease progression or new metastases after prior chemoembolization
- No prior systemic chemotherapy for this cancer
- No other concurrent chemotherapy
- More than 4 weeks since prior hormonal therapy
- See Disease Characteristics
At least 6 weeks since prior radiofrequency ablation or other local ablative therapy
- Patients must have evidence of disease progression or new metastases after prior radiofrequency ablation or other local ablative therapy
- No prior external beam radiotherapy to the primary site
- No prior radiotherapy to ≥ 25% of the bone marrow
- No concurrent radiotherapy
- See Disease Characteristics
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent drugs or biologics with proarrhythmic potential
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 |
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Experimenteel: Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a CR receive 2 additional courses beyond CR.
Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment.
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Correlatieve studies
Mondeling gegeven
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Survival after 6 months of treatment
Tijdsspanne: 6 months
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Will be estimated by the proportion of patients surviving more than 6 months.
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
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6 months
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Time to disease progression
Tijdsspanne: From registration to documentation of disease progression, assessed up to 5 years
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Will be estimated using the method of Kaplan-Meier.
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From registration to documentation of disease progression, assessed up to 5 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Tijdsspanne: Up to 5 years
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Up to 5 years
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Laboratory measures
Tijdsspanne: Up to 5 years
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Descriptive statistics will be computed for the laboratory measures, including frequency and Cox proportional hazards modeling.
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Up to 5 years
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire 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
- Ziekten van het spijsverteringsstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Adenocarcinoom
- Neoplasmata, glandulair en epitheel
- Neoplasmata van het spijsverteringsstelsel
- Lever Ziekten
- Carcinoom
- Carcinoom, hepatocellulair
- Lever neoplasmata
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Cediranib
Andere studie-ID-nummers
- NCI-2012-01822
- U10CA025224 (Subsidie/contract van de Amerikaanse NIH)
- N044J
- CDR0000446081
- NCCTG-N044J
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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