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
2 other identifiers
interventional
78
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedNovember 18, 2015
November 1, 2015
4.3 years
January 25, 2010
November 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of Escalating Doses of Hepatic Arterial Infusions of Abraxane in Combination with Gemcitabine and Bevacizumab
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.
21 days
Study Arms (1)
HAI Abraxane + Gemcitabine + Bevacizumab
EXPERIMENTALHAI (hepatic arterial infusions) Abraxane with Gemcitabine + Bevacizumab
Interventions
Starting dose: 120 mg/m\^2 by HAI infusion over 24 hours on Day 1 of 21 day cycle
Starting dose: 600 mg/m\^2 by IV on Days 1 and 8 of 21 day cycle
10 mg/kg IV on Day 1 of 21 day cycle
5 mcg/kg subcutaneously starting at least 24 hours after Day 1 completion of chemotherapy, for 3 days.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Apostolia M. Tsimberidou, MD, PHD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 27, 2010
Study Start
January 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
November 18, 2015
Record last verified: 2015-11