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HAI Abraxane With Gemcitabine and Bevacizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01057264
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: HAI Abraxane Drug: Gemcitabine Drug: Bevacizumab Drug: Filgrastim Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HAI Abraxane + Gemcitabine + Bevacizumab
HAI (hepatic arterial infusions) Abraxane with Gemcitabine + Bevacizumab
Drug: HAI Abraxane
Starting dose: 120 mg/m^2 by HAI infusion over 24 hours on Day 1 of 21 day cycle
Other Names:
  • Nab-paclitaxel
  • Paclitaxel (protein bound)
  • ABI-007

Drug: Gemcitabine
Starting dose: 600 mg/m^2 by IV on Days 1 and 8 of 21 day cycle
Other Names:
  • Gemzar
  • Gemcitabine Hydrochloride

Drug: Bevacizumab
10 mg/kg IV on Day 1 of 21 day cycle
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Drug: Filgrastim
5 mcg/kg subcutaneously starting at least 24 hours after Day 1 completion of chemotherapy, for 3 days.
Other Names:
  • G-CSF
  • Neupogen

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Escalating Doses of Hepatic Arterial Infusions of Abraxane in Combination with Gemcitabine and Bevacizumab [ Time Frame: 21 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 </= 2.0 mg/dL or the calculated glomerular filtration rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL).
  5. Hepatic function: Total bilirubin </= 5 mg/dL, alanine transaminase (ALT) </= 5 times 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057264

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Apostolia M. Tsimberidou, MD, PHD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01057264    
Other Study ID Numbers: 2009-0741
NCI-2011-00555 ( Registry Identifier: NCI CTRP )
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by M.D. Anderson Cancer Center:
Hepatic arterial infusion
Gemcitabine Hydrochloride
Anti-VEGF monoclonal antibody
Additional relevant MeSH terms:
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Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors