Clinical trial · Interventional
Doxorubicin and Bortezomib in Treating Patients With Liver Cancer
A Phase II Trial of Bortezomib Plus Doxorubicin in Hepatocellular Carcinoma
NCT00083226CI-TRIAL-00015946completedPhase 2Results postedClinicalTrials.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)
This phase II trial is studying how well giving doxorubicin together with bortezomib works in treating patients with liver cancer. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving doxorubicin together with bortezomib may kill more tumor cells.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (doxorubicin+bortezomib)
- description
- Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib at a dose of 1.3 mg/m\^2 IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: doxorubicin
- Drug: bortezomib
Primary outcomes (1)
- measure
- Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)
- timeFrame
- assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year
- description
- Tumor response was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Objective response rate included complete response (disappearance of all tumor lesions) and partial response (At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have microscopically confirmed hepatocellular carcinoma not amenable to curative resection; if patients have an isolated lesion in one lobe of the liver, a liver surgeon should determine resectability; central review is not required * Patients must have measurable disease as determined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, amenable to biopsy; patients are not mandated to allow biopsy, even though it is an important aspect of this clinical trial * Patients with history of malignancy treated within the past 5 years are not eligible; history of carcinoma-in-situ of cervix, squamous cell cancer of skin, basal cell cancer of skin, previously treated are allowed; others are excluded as recurrence of disease may confuse response rate and/or survival endpoints * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Patients must not have had prior systemic chemotherapy for HCC; patients on antineoplastics for non-malignant diseases, such as methotrexate for rheumatoid arthritis, are allowed, providing patients have been off these agents for at least 4 weeks and all related toxicities have resolved to baseline * Patients may have had prior embolization without chemotherapy; patients who have had chemoembolization are not eligible; patients may have had radiofrequency (RF) ablation, cryosurgery or ethanol injection; patients must have documented progression with the involved lesion or at least one previously untreated lesion amenable to biopsy * Platelet count must be \>= 100,000/mm\^3 in absence of splenomegaly; platelet count must be \>= 75,000/mm\^3 with splenomegaly * Absolute neutrophil count (ANC) must be \>= 1,500/mm\^3 in absence of splenomegaly; ANC must be =\< 1,000/mm\^3 with splenomegaly * Alkaline phosphate (ALT) must be =\< 5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) must be =\< 5 x institutional ULN * Bilirubin must be =\< 2 mg/dl * Patients may not exhibit Child Pugh scale grade C cirrhosis * Serum creatinine=\< 2.0 mg/dl * All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception * Patients must not have known bleeding diathesis, international normalized ratio (INR) \> 1.5 or Partial thromboplastin time (PTT) \> 1.5 x institutional ULN (required due to biopsy portion of study); use of vitamin K or fresh frozen plasma to correct values just prior to biopsy or enrollment is not allowed are not eligible Exclusion criteria: * Patients have baseline peripheral neuropathy \> grade 1 * Patients with history of untreated malignancy other than HCC * Patients have had prior use of octreotide or tamoxifen as therapy for HCC * Patients with known allergy to boron, mannitol or bortezomib * Women are pregnant or breast-feeding (due to the uncertain effects of bortezomib in the developing fetus and young infants) * Patients have an underlying medical condition that precludes safe participation in this clinical trial * Patients have psychiatric illness or continued substance abuse that may impair the ability to provide informed consent or prevent safe administration of bortezomib * Patients with ejection fraction (EF) \< 50% measured by Echocardiography (ECHO) or Multiple gated acquisition (MUGA) * Patients on verapamil who cannot be switched to an alternative medication (due to the interaction with doxorubicin)
References
Publications (1)
- DERIVEDCiombor KK, Feng Y, Benson AB 3rd, Su Y, Horton L, Short SP, Kauh JS, Staley C, Mulcahy M, Powell M, Amiri KI, Richmond A, Berlin J. Phase II trial of bortezomib plus doxorubicin in hepatocellular carcinoma (E6202): a trial of the Eastern Cooperative Oncology Group. Invest New Drugs. 2014 Oct;32(5):1017-27. doi: 10.1007/s10637-014-0111-8. Epub 2014 Jun 4. PMID 24890858