Hepatic Arterial Infusion (HAI) of Abraxane

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Comprehensive Cancer Network
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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.