Trials / Terminated
TerminatedNCT00047333
Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed description
PRIMARY OBJECTIVES: I. To assess progression-free survival (PFS) measured at 16 weeks following initiation of once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular carcinoma. SECONDARY OBJECTIVES: I. To assess objective response rate, rate and duration of stable disease, time to progression, median and overall survival in this patient population, and any changes in tumor perfusion based on functional CT imaging. II. To correlate response with patient characteristics including: age, disease stage (TNM, Okuda \[6\]), viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, Performance Status, serum values of: alpha feto-protein, bilirubin, transaminases, albumin; EGFR expression score by IHC; and development of skin rash during therapy. III. To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient population. IV. To determine the safety and tolerability of OSI-774 in this patient population. OUTLINE: Patients are stratified according to epidermal growth factor receptor expression (low, 0-1+ vs high, 2-3+). Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
Conditions
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | erlotinib hydrochloride | Given PO |
| OTHER | laboratory biomarker analysis | Correlative studies |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2002-08-01
- Primary completion
- 2006-01-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00047333. Inclusion in this directory is not an endorsement.