Trials / Completed
CompletedNCT00077441
Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well bortezomib works in treating patients with hepatocellular carcinoma (liver cancer) that cannot be removed with surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Detailed description
PRIMARY OBJECTIVES: I. Proportion of confirmed tumor responses. SECONDARY OBJECTIVES: I. To evaluate the confirmed and objective response rate. II. To assess patient outcome as estimated by duration of response, time to disease progression, and survival. III. To evaluate the adverse event rates associated with PS-341 in this population. IV. To explore the relationships between laboratory correlates (eg. IHC) and patient outcome (eg p53 and disease progression). V. To evaluate alterations in laboratory correlates from pre-treatment measurements (ie, pre and post treatment). The following immunohistochemistry (IHC) assays will be performed: IHC of p53, IHC of p21, IHC of p27, IHC of NFkB, IHC of Ki67. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.
Conditions
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bortezomib | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2006-06-01
- First posted
- 2004-02-12
- Last updated
- 2013-06-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00077441. Inclusion in this directory is not an endorsement.