Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Histologically or cytologically confirmed hepatocellular carcinoma (HCC) Locally advanced, recurrent, or metastatic Not candidates for surgical/radical therapies Other solid tumor that is incurable (closed to accrual as of 11/7/03) At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Target lesion may not be in a previously irradiated field unless subsequent progression was documented No ascites No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 3 months Hematopoietic WBC at least 2,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.0 mg/dL AST no greater than 5 times upper limit of normal (ULN) Albumin greater than 3.5 g/dL No cirrhosis worse than Childs-Pugh class A Renal Creatinine no greater than 1.25 times ULN OR Creatinine clearance at least 50 mL/min Cardiovascular LVEF normal by MUGA No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Good nutritional status No encephalopathy No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No prior allergic reactions to compounds of similar chemical or biological composition to oblimersen or doxorubicin Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No more than 1 prior biologic therapy regimen for patients with HCC At least 4 weeks since prior biologic therapy Chemotherapy Patients with HCC: No prior systemic chemotherapy Prior chemotherapy as part of localized chemoembolization therapy may be allowed (no more than 150 mg/m^2 for doxorubicin) if completed at least 8 weeks before study treatment All other patients (closed to accrual as of 11/7/03): At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior doxorubicin, epirubicin, or other anthracycline Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No more than 3,000 cGy to fields including substantial bone marrow Surgery At least 8 weeks since prior surgery Prior liver transplant for HCC allowed Other Recovered from all prior therapy At least 8 weeks since other locally ablative therapies No concurrent commercial or other investigational agents or therapies No other concurrent anticancer therapy No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- British Columbia Cancer Agency - Vancouver Cancer Centre
- London Regional Cancer Program at London Health Sciences Centre
- Princess Margaret Hospital
Arms of the Study
Arm 1
Experimental
G3139 in combination with Doxorubicin