Bortezomib in Treating Patients With Advanced Cancer and Liver Dysfunction
Completed · Phase 1
Conditions studied: Hepatic Complications, Malignant Neoplasm
In brief
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.
Key facts
- Study ID
- NCT00091117
- Run by
- National Cancer Institute (NCI)
- People needed
- 80
- Starts
- 2004-07-01
- Last updated by the study team
- 2013-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- City of Hope Medical Center — Duarte, California, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Wayne State University — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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