Overview

HAI Abraxane With Gemcitabine and Bevacizumab

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Albumin-Bound Paclitaxel
Antibodies
Antibodies, Monoclonal
Bevacizumab
Gemcitabine
Lenograstim
Paclitaxel
Criteria
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 filtration rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL).

5. Hepatic function: Total bilirubin 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).