Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced unresectable hepatocellular carcinoma (liver cancer ).

Further Study Information

OBJECTIVES:

Primary

• Determine the 4.5-month progression-free survival rate in patients with advanced unresectable hepatocellular carcinoma treated with gefitinib.

Secondary

• Determine the response rate (complete and partial), in terms of the effects of this drug on measurable disease and serum alpha-fetoprotein levels, in these patients.

• Determine the overall survival of patients treated with this drug.

• Determine the toxicity of this drug in these patients.

• Correlate epidermal growth factor expression at baseline with clinical response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for 3 years from study entry.

PROJECTED ACCRUAL: A total of 23-59 patients will be accrued for this study within 19 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of advanced unresectable hepatocellular carcinoma based on 1 of the following criteria:

• Histologically or cytologically confirmed disease

• Hepatitis B surface antigen negative and alpha-fetoprotein greater than 400 ng/mL

• Hepatitis B surface antigen positive and alpha-fetoprotein greater than 4,000 ng/mL

• At least 1 unidimensionally measurable lesion

• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• Outside prior radiotherapy field

• No known brain metastases

• Ineligible for surgical resection or liver transplantation

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,000/mm^3

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 50,000/mm^3

Hepatic

• See Disease Characteristics

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• AST no greater than 5 times ULN

• PT no greater than 6 seconds over control

• INR no greater than 2.3

• Albumin at least 2.8 g/dL

• No Child Pugh Scale class C cirrhosis

Renal

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other active malignancy requiring therapy except nonmelanoma skin cancer

• No prior allergic reactions attributed to compounds of similar chemical or biological composition to gefitinib

• No psychiatric illness or social situation that would preclude study compliance

• No grade 3 or 4 encephalopathy

• No other concurrent uncontrolled illness

• No ongoing or active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy

• Prior interferon alfa or interferon beta for hepatitis B or C allowed provided the therapy was completed before the diagnosis of hepatocellular carcinoma

• No prior antiangiogenesis therapy

Chemotherapy

• No prior systemic chemotherapy

Endocrine therapy

• No concurrent dexamethasone

• No concurrent glucocorticoids

• No concurrent progesterone

Radiotherapy

• See Disease Characteristics

• At least 2 weeks since prior palliative radiotherapy

Surgery

• Not specified

Other

• Prior liver-directed therapy (i.e., radiofrequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization, and hepatic artery-infused floxuridine) allowed provided patient has progressive hepatic disease or measurable extrahepatic disease

• No prior epidermal growth factor inhibitor therapy

• No other concurrent investigational or commercial anticancer agents or therapies

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent inducers of CYP3A4, including the following:

• Carbamazepine

• Ethosuximide

• Griseofulvin

• Nafcillin

• Nelfinavir

• Nevirapine

• Oxcarbazepine

• Phenobarbital

• Phenylbutazone

• Phenytoin

• Primidone

• Rifabutin

• Rifampin

• Rofecoxib

• Hypericum perforatum (St. John's wort)

• Sulfadimidine

• Sulfinpyrazone

• Troglitazone

• Efavirenz

• Modafinil

• Rifapentine

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Bruce J. Giantonio

Study Chair

Jordan D. Berlin

Study Chair

Peter J. O'Dwyer

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00071994
Information obtained from ClinicalTrials.gov on December 14, 2011

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