Clinical trial · Interventional
Bortezomib in Treating Patients With Advanced Cancer and Liver Dysfunction
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
NCT00091117CI-TRIAL-00013001completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Complications | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bortezomib
- Other: pharmacological study
Primary outcomes (2)
- measure
- DLT
- timeFrame
- 21 days
- measure
- MTD
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLoRusso PM, Venkatakrishnan K, Ramanathan RK, Sarantopoulos J, Mulkerin D, Shibata SI, Hamilton A, Dowlati A, Mani S, Rudek MA, Takimoto CH, Neuwirth R, Esseltine DL, Ivy P. Pharmacokinetics and safety of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction: phase I NCI Organ Dysfunction Working Group Study NCI-6432. Clin Cancer Res. 2012 May 15;18(10):2954-63. doi: 10.1158/1078-0432.CCR-11-2873. Epub 2012 Mar 6. PMID 22394984