Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Massachusetts General Hospital National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00427973 |
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer |
Drug: cediranib maleate Procedure: computed tomography Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: laboratory biomarker analysis Procedure: pharmacological study Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of AZD2171 in Hepatocellular Carcinoma |
Estimated Enrollment: | 34 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Dynamic contrast-enhanced (DCE) MRI and CT perfusion scan of the liver are performed at baseline, 72 hours after the initial dose of AZD2171, and at the end of course 1.
Blood samples for pharmacokinetic studies are collected on days 8 and 15 of course 1 and periodically during course 2. Blood samples are also examined for soluble markers of angiogenesis and tumor markers by protein analysis.
After the completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatocellular carcinoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
No other uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000526405, MGH-05-311 |
Study First Received: | January 25, 2007 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00427973 |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Recurrence Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |