Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Drug: cediranib maleate
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma|
- Survival after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Time to disease progression [ Time Frame: From registration to documentation of disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]Will be estimated using the method of Kaplan-Meier.
- 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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Laboratory measures [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Descriptive statistics will be computed for the laboratory measures, including frequency and Cox proportional hazards modeling.
|Study Start Date:||December 2005|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: cediranib maleate
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238394
|United States, Minnesota|
|North Central Cancer Treatment Group|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Steven Alberts||North Central Cancer Treatment Group|