HAI Abraxane With Gemcitabine and Bevacizumab
Completed · Phase 1
Conditions studied: Advanced Cancers
In brief
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.
Key facts
- Study ID
- NCT01057264
- Run by
- M.D. Anderson Cancer Center
- People needed
- 78
- Starts
- 2010-01-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2015-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Pregnant females.
- 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.
- Patients already in uncompensated liver failure (i.e. Child Pugh Liver Classification C).
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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