Clinical trial NCT00047229 (phase 2, status: completed)
Conditions: liver cancer
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: doxorubicin hydrochloride
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
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