HAI Abraxane With Gemcitabine and Bevacizumab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01057264
First received: January 25, 2010
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Advanced Cancers
Drug: HAI Abraxane
Drug: Gemcitabine
Drug: Bevacizumab
Drug: Filgrastim
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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


Enrollment: 78
Study Start Date: January 2010
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057264

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Apostolia M. Tsimberidou, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01057264     History of Changes
Other Study ID Numbers: 2009-0741, NCI-2011-00555
Study First Received: January 25, 2010
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Liver
Cancer
Hepatic arterial infusion
HAI
Abraxane
Nab-Paclitaxel
Paclitaxel
ABI-007
Gemcitabine
Gemcitabine Hydrochloride
Gemzar
Bevacizumab
Avastin
Anti-VEGF monoclonal antibody
rhuMAb-VEGF
Filgrastim
G-CSF
Neupogen

Additional relevant MeSH terms:
Neoplasms
Antibodies
Antibodies, Monoclonal
Gemcitabine
Lenograstim
Bevacizumab
Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014