Clinical trial · Interventional
AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer
A Phase II Study of AZD2171 in Hepatocellular Carcinoma
NCT00427973CI-TRIAL-00024509terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped prior to 2nd stage.
Summary
Brief summary (as posted)
This phase II trial is studying how well AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cediranib maleate | Drug | Cediranib | ALIAS |
| computed tomography | Procedure | — | UNRESOLVED |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD2171
- description
- Patients will receive AZD2171 (cediranib maleate) 30mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
- interventionNames
- Drug: cediranib maleate
- Other: laboratory biomarker analysis
- Procedure: computed tomography
- Procedure: dynamic contrast-enhanced magnetic resonance imaging
- Other: pharmacological study
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 3 months
- description
- Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first. This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular carcinoma * Locally advanced unresectable OR metastatic disease * Cancer of the Liver Italian Program (CLIP) score =\< 3 * Symptomatic congestive heart failure * Unstable angina pectoris * Measurable disease, defined as \>= 1 unidimensionally measurable lesion\>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan * Cardiac arrhythmia * Measurable lesion must be outside field of prior chemoembolization * No known brain metastases * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 12 weeks * Absolute neutrophil count \>= 1,000/mm\^3 * Platelet count \>= 75,000/mm\^3 * Hemoglobin \>= 8 g/dL * Bilirubin =\< 3.0 mg/dL * AST and ALT =\< 7 times upper limit of normal * Creatinine =\< 2.0 mg/dL * Fertile patients must use effective contraception * CLIP score =\< 3 Exclusion Criteria: * Not pregnant or nursing * Negative pregnancy test * No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD2171 * No chronic diarrhea or any disorder that would limit adequate absorption of AZD2171 * No familial history of long QT syndrome * Proteinuria =\< +1 on two consecutive dipsticks taken no less than 1 week apart * No other uncontrolled illness including, but not limited to, any of the following: * Hypertension * Ongoing or active infection * No psychiatric illness or social situation that would limit study compliance * Recovered from prior therapy * Prior systemic chemotherapy regimens for hepatocellular carcinoma allowed * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * More than 4 weeks since prior radiotherapy, major surgery, or chemoembolization * At least 30 days since prior participation in an investigational trial * No other concurrent investigational agents * No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine) * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents or therapies * No mean QTc \> 470 msec (with Bazett's correction) on screening EKG (490 msec for women)
References
Publications (1)
- RESULTZhu AX, Ancukiewicz M, Supko JG, Sahani DV, Blaszkowsky LS, Meyerhardt JA, Abrams TA, McCleary NJ, Bhargava P, Muzikansky A, Sheehan S, Regan E, Vasudev E, Knowles M, Fuchs CS, Ryan DP, Jain RK, Duda DG. Efficacy, safety, pharmacokinetics, and biomarkers of cediranib monotherapy in advanced hepatocellular carcinoma: a phase II study. Clin Cancer Res. 2013 Mar 15;19(6):1557-66. doi: 10.1158/1078-0432.CCR-12-3041. Epub 2013 Jan 29. PMID 23362324