Clinical trial · Interventional
Hepatic Arterial Infusion (HAI) of Abraxane
Phase I Trial of Hepatic Arterial Infusion of Abraxane With a Pharmacokinetic Study in Advanced Solid Cancer Patients With Predominant Hepatic Metastases
NCT00732836CI-TRIAL-00020815completedPhase 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)
The goal of this clinical research study is find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAI Abraxane | Drug | — | UNRESOLVED |
| Hepatic Artery Catheter | Procedure | — | UNRESOLVED |
| IV Abraxane | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HAI Abraxane MTD
- description
- Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m\^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle.
- interventionNames
- Drug: HAI Abraxane
- Procedure: Hepatic Artery Catheter
- Drug: IV Abraxane
- type
- EXPERIMENTAL
- label
- HAI Abraxane Expansion
- description
- HAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m\^2) if MTD not defined.
- interventionNames
- Drug: HAI Abraxane
- Procedure: Hepatic Artery Catheter
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed diagnosis of advanced malignancy and liver involvement as predominant site of metastasis. 2. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 3. Adequate end-organ function as follows: Absolute neutrophil count (ANC) \> or = 1500/mm3, Platelets \> or = 100,000/mm3, Creatinine \< or = 2.0 mg/dL or the calculated Glomerular filtration rate (GFR) \> or = 40 mL/min if Creatinine \> 2.0 mg/dL, ALT \< or = 5 times upper limits of normal, Hb \> 9.0 and Bilirubin \< or = 2.0 mg/dL. 4. Refractory to standard cancer therapy or who have no conventional therapy that produces a complete response rate of at least 10% or an increase in survival of at least 3 months. 5. Ability to fully comprehend and willingness to sign the Institutional Review Board (IRB) approved informed consent 6. Full recovery from any previous therapy and ability to receive cytotoxic agents. 7. Patient is 18 years of age or older Exclusion Criteria: 1. Clinically significant ascites. 2. Pregnant or breastfeeding females. Women of childbearing potential should be advised to avoid becoming pregnant and men to not father a child while receiving treatment. Women of childbearing potential must have a negative pregnancy test. 3. Hypersensitivity to Abraxane 4. Untreatable bleeding diathesis 5. Evidence of portal vein thrombosis and clinically significant peripheral vascular disease 6. Neuropathy of grade 2 or higher 7. A known history of central nervous system (CNS) metastasis unless the patients are neurologically stable after treatment with surgery and/or radiation therapy 8. If the patient progressed on abraxane previously they will not be eligible for the dose escalation portion or the PK studies only. These patients can be included in the dose expansion portion of the trial.
References
Publications (1)
- DERIVEDSiqing F, Culotta KS, Falchook GS, Hong DS, Myers AL, Zhang YP, Naing A, Janku F, Hou MM, Kurzrock R. Pharmacokinetic evaluation of nanoparticle albumin-bound paclitaxel delivered via hepatic arterial infusion in patients with predominantly hepatic metastases. Cancer Chemother Pharmacol. 2016 Feb;77(2):357-64. doi: 10.1007/s00280-015-2946-x. Epub 2015 Dec 23. PMID 26698868