NCT00238394

Brief Summary

AZD2171 (cediranib maleate) 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. This phase II trial is studying how well AZD2171 works in treating patients with locally advanced or metastatic liver cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

October 12, 2005

Last Update Submit

June 4, 2013

Conditions

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (2)

  • Survival after 6 months of treatment

    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.

    6 months

  • Time to disease progression

    Will be estimated using the method of Kaplan-Meier.

    From registration to documentation of disease progression, assessed up to 5 years

Secondary Outcomes (2)

  • 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

    Up to 5 years

  • Laboratory measures

    Up to 5 years

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

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.

Drug: cediranib maleateOther: laboratory biomarker analysis

Interventions

cediranib maleateDRUG

Given orally

Also known as: AZD2171, Recentin
Treatment (cediranib maleate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (cediranib maleate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

cediranib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Steven Alberts

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

December 1, 2005

Primary Completion

March 1, 2007

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)