Trials / Completed
CompletedNCT00238394
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cediranib maleate | Given orally |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2007-03-01
- First posted
- 2005-10-13
- Last updated
- 2013-06-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00238394. Inclusion in this directory is not an endorsement.