Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction

Conditions

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• erlotinib hydrochloride — DRUG
  Given PO
• pharmacological study — OTHER
  Correlative studies
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

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

Key Dates

First listed

Jan 27, 2003

Start date

Aug 31, 2002

Status verified

Jan 2013

Primary completion

Dec 31, 2005

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (erlotinib hydrochloride)
  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.

Primary Outcome Measure

Dose-limiting toxicity and maximum tolerated dose as measured by NCI CTCAE v3.0 continuously [ Time Frame: 28 days ]

Locations (1)

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