Bortezomib in Treating Patients With Advanced Cancer and Liver Dysfunction

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. This phase I trial is studying the side effects and best dose of bortezomib in treating patients with advanced cancer and liver dysfunction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib

Criteria

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