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.
Drug: HAI Abraxane
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Full eligibility criteria for NCT01057264
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients must have histologically confirmed cancer with metastatic liver metastases.
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.
Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities).
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).
Hepatic function: Total bilirubin </= 5 mg/dL, alanine transaminase (ALT) </= 5 times upper normal reference value.
Adequate bone marrow function (absolute neutrophil count (ANC) >/= 1500 cells/uL; platelets (PLT) >/= 100,000 cells/uL).
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.
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.
Must be >/= 18 years of age.
Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
Serious or non-healing wound, ulcer or bone fracture.
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg).
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.
Tris trial is registered with FDA with number: NCT01057264. The sponsor of the trial is M.D. Anderson Cancer Center and it is looking for 78 volunteers for the current phase.
Official trial title: 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
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