Trials / Completed
CompletedNCT00047346
Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction
A Dose-Finding, Safety, And Pharmacokinetic Study Of The Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor OSI-774 (NSC 718781) In Patients With Unresectable Hepatocellular Carcinoma And Moderate Hepatic Dysfunction
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase I trial to study the effectiveness of erlotinib in treating patients who have unresectable liver cancer and liver dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
Detailed description
PRIMARY OBJECTIVES: I. Establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of OSI-774 in patients with unresectable hepatocellular carcinoma (HCC) with moderate liver dysfunction. II. Establish the pharmacokinetic and pharmacodynamic profile of OSI-774 in HCC patients with moderate liver dysfunction. SECONDARY OBJECTIVES: I. Assess possible anti-tumor effects of OSI-774 in patients with advanced hepatocellular carcinoma in terms of partial response (PR) and complete response (CR) as assessed by tumor shrinkage by RECIST criteria. OUTLINE: This is a dose-escalation study. Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 | erlotinib hydrochloride | Given PO |
| OTHER | pharmacological study | Correlative studies |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2002-08-01
- Primary completion
- 2005-12-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00047346. Inclusion in this directory is not an endorsement.