A Phase I Pharmacokinetic Study of PS-341 in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction for the CTEPSponsored Organ Dysfunction Working Group

Date de début de l'étude : 1 juillet 2004

Inclusion Criteria: * Histologically confirmed malignancy for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists * Tumor types may include any of the following: solid tumors: * Non-Hodgkin's lymphoma * Hepatocellular carcinoma, as evidenced by liver mass, elevated alpha-fetoprotein level (\>= 500 ng/mL), and positive serology for hepatitis * Pathological confirmation is not required * Confirmatory evidence for a prior Hepatitis B infection (HBsAg, HBcAb and/or HBsAb) required * No symptomatic CNS metastases * Brain metastasis allowed if the following criteria are met: * Received prior definitive treatment (radiation and/or surgery * Stable disease for \>= 4 weeks * Not currently on enzyme-inducing anticonvulsants and steroids * Life expectancy of at least 12 weeks * Absolute neutrophil count \>= 1,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Biliary obstruction for which a shunt has been placed allowed provided the shunt has been in place for \>= 10 days AND liver function is stable, defined as 2 measurements taken \>= 2 days apart that qualify the patient for the same hepatic dysfunction stratum * No biliary sepsis * Creatinine =\< 1.5 mg/dL * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No New York Heart Association class III or IV heart disease * Not pregnant or nursing * Negative pregnancy test * No preexisting neuropathy \>= grade 2 * No ongoing or active infection * No other concurrent uncontrolled illness that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * More than 4 weeks since prior immunotherapy * More than 4 weeks since prior biologic therapy * No concurrent prophylactic colony-stimulating factors * No concurrent immunotherapy * No concurrent thalidomide * Concurrent epoetin alfa or darbepoetin alfa for management of cancer-associated anemia allowed * Recovered from prior chemotherapy (not including liver function) * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy * More than 2 weeks since prior radiotherapy * No prior radiotherapy to \> 50% of the bone marrow * No concurrent radiotherapy * More than 3 weeks since prior surgery * No prior bortezomib * No concurrent antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * Concurrent cytochrome P450 interacting agents are allowed provided they are used with caution * Concurrent bisphosphonate therapy allowed (e.g., pamidronate or zoledronate), except during course 1 of bortezomib administration * ECOG 0-2 * Fertile patients must use effective contraception during and for 30 days after study participation