- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- North Central Cancer Treatment Group
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Korrelative undersøgelser
Gives oralt
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Survival after 6 months of treatment
Tidsramme: 6 months
|
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
Tidsramme: From registration to documentation of disease progression, assessed up to 5 years
|
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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: Up to 5 years
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Up to 5 years
|
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Laboratory measures
Tidsramme: Up to 5 years
|
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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- Karcinom
- Carcinom, hepatocellulært
- Neoplasmer i leveren
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Cediranib
Andre undersøgelses-id-numre
- NCI-2012-01822
- U10CA025224 (U.S. NIH-bevilling/kontrakt)
- N044J
- CDR0000446081
- NCCTG-N044J
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