Clinical trial · Interventional
HAI Abraxane With Gemcitabine and Bevacizumab
A Phase I Study of Hepatic Arterial Infusion (HAI) of Abraxane in Combination With Gemcitabine and Bevacizumab for Patients With Advanced Cancers Metastatic to the Liver
NCT01057264CI-TRIAL-00019839completedPhase 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 to find the highest tolerable dose of Abraxane® (nab-paclitaxel) when given directly into the liver, in combination with Gemzar® (gemcitabine) and Avastin® (bevacizumab) when given by vein.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| HAI Abraxane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HAI Abraxane + Gemcitabine + Bevacizumab
- description
- HAI (hepatic arterial infusions) Abraxane with Gemcitabine + Bevacizumab
- interventionNames
- Drug: HAI Abraxane
- Drug: Gemcitabine
- Drug: Bevacizumab
- Drug: Filgrastim
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Escalating Doses of Hepatic Arterial Infusions of Abraxane in Combination with Gemcitabine and Bevacizumab
- timeFrame
- 21 days
- description
- If not more than 33% of the patients in the cohort develop dose limiting toxicities (DLT), this cohort considered maximum tolerated dose (MTD). Dose-limiting toxicity (DLT) defined as any grade 3 or 4 non-hematologic toxicity as defined in the most current version of NCI Common Toxicity Criteria for Adverse Effects (CTCAE). MTD defined by DLTs that occur in the first cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically confirmed cancer with metastatic liver metastases. 2. Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months, unless the drugs in the protocol regimen are part of the standard of care. 3. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities). 4. Adequate renal function (serum creatinine \</= 2.0 mg/dL or the calculated glomerular filtration rate (GFR) \>/= 40 mL/min if creatinine \> 2.0 mg/dL). 5. Hepatic function: Total bilirubin \</= 5 mg/dL, alanine transaminase (ALT) \</= 5 times upper normal reference value. 6. Adequate bone marrow function (absolute neutrophil count (ANC) \>/= 1500 cells/uL; platelets (PLT) \>/= 100,000 cells/uL). 7. At least three weeks from previous cytotoxic chemotherapy before day 1 of hepatic arterial infusion (HAI) infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter. 8. All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control. 9. Must be \>/= 18 years of age. Exclusion Criteria: 1. Pregnant females. 2. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements. 3. Serious or non-healing wound, ulcer or bone fracture. 4. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. 5. Uncontrolled systemic vascular hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg). 6. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements. 7. Patients already in uncompensated liver failure (i.e. Child Pugh Liver Classification C).
References
Publications (0)
Data not yet available
No reference posted for this study.