Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
Completed · Phase 2
Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
In brief
Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced unresectable hepatocellular carcinoma (liver cancer). Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Key facts
- Study ID
- NCT00071994
- Run by
- National Cancer Institute (NCI)
- People needed
- 59
- Starts
- 2004-02-01
- Last updated by the study team
- 2013-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have advanced unresectable hepatocellular carcinoma based on the following criteria:
- Histologically or cytologically confirmed, OR
- Alpha-fetoprotein > 400 ng if patient is not hepatitis surface antigen positive, OR
- Alpha-fetoprotein > 4000 ng if patient is hepatitis surface antigen positive
- NOTE: If available, tissue should be submitted to assess EGFR/pathway expression
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, assessed within 4 weeks prior to randomization/registration
- Prior use of liver-directed therapy (radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization and hepatic artery infused FUDR) is allowed, provided the patient has either progressive hepatic disease or measurable extrahepatic disease
- ECOG performance status of 0, 1 or 2
- Leukocytes >= 2,000/uL OR
- Absolute neutrophil count >= 1,000/uL
- Platelets >= 50,000/uL
- Patients may not have Child Pugh Scale's class C cirrhosis
- AST (SGOT) =< 5 x institutional upper limit of normal
- Total bilirubin =< 2 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
- PT =< 6 seconds over control
- INR =< 2.3
- Albumin >= 2.8 g/dL
- Pregnant women are excluded from this study; sexually active women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of their participation in the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Women who are breastfeeding a child are not eligible, unless they discontinue the breastfeeding
- Patients must not have had prior systemic chemotherapy, biologic therapy or antiangiogenesis therapy; prior therapy with interferon alpha or interferon beta for treatment of hepatitis B or C is allowed provided
- Prior palliative radiotherapy is permissible provided it has been completed 2 weeks from registration and the patient has measurable disease outside the radiation field
- Patients may not be receiving any other investigational agents
- Patients must not have a history of other malignancies that are active and require therapy (other than local therapies for non melanoma skin cancers)
- Patients must not have known brain metastases; their poor prognosis would present challenges and their tendency to develop progressive neurologic dysfunction would confound the evaluation of neurologic and other adverse events
Where it is running
- Eastern Cooperative Oncology Group — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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