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Gemcitabine (GEMZAR) Plus ABI-007 (ABRAXANE)In Patients With Advanced Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
First Received: November 8, 2006   Last Updated: June 8, 2009   History of Changes
Sponsored by: Abraxis BioScience Inc.
Information provided by: Abraxis BioScience Inc.
ClinicalTrials.gov Identifier: NCT00398086
  Purpose

To determine the MTD and DLT of Gemcitabine plus ABI-007 in patients with advanced metastatic pancreatic cancer


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: ABI-007 plus Gemcitabine
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Abraxis BioScience Inc.:

Primary Outcome Measures:
  • Determine the MTD and DLT of gemcitabine plus ABI-007 in patients with advanced metastatic pancreatic cancer. [ Time Frame: Enrollment and treatment period 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of this combination in this patients population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Report any objective antitumor responses and disease stabilization lasting at least 4 cycles. [ Time Frame: End of Study/ Follow up ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: November 2006
Estimated Study Completion Date: February 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: ABI-007 plus Gemcitabine
3 patients entered at low dose A, If no DLT-3 more patients enrolled at dose B Number of cycles:until progression or inacceptable toxicity develops

Detailed Description:

ABI-007 is a novel, solvent-free, albumin-bound, 130 nanometer particle form of paclitaxel designed to avoid the problems associated with solvents used in Taxol(Abraxane prescribing information 2005). Albumin has a number of properties that make it an attractive molecule to combine with paclitaxel. Albumin is a natural transporter of endogenous hydrophobic molecules such as water-insoluble vitamins and hormones (Vorum 1999)and albumin binding to the gp-60 receptor (albondin) initiates the caveolae-mediated endothelial transport of protein-bound and unbound plasma constituents (John et al 2003, Minshall et al 2003, Tiruppathi et al 1997).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
  • Male or non-pregnant and non-lactating female, and age greater or equal to 18.
  • If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (B-hCG)documented within 72 hours of the first administration of study drug.
  • If sexually active, the patient must agree to use contraception considered adequate and appropriate by the investigator.
  • Patient must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a patient received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at least 6 months after completing the last dose of gemcitabine.
  • Patient has the following blood counts at baseline
  • ANC equal or greater to 1.5 x 10^9/L;
  • Platelets equal or greater to 100 x 10^9/L
  • Hgb equal or greater to 9g/dL.
  • Patient has the following blood chemistry levels at baseline:
  • AST (SGOT), ALT (SGPT)equal or less than 2.5 x upper limit of normal range (ULN)is allowed
  • Bilirubin less than or equal to ULN
  • Serum creatinine within normal limits or calculated clearance equal or greater to 60 mL/min/1.73M^2 patients with serum creatinine levels above the institutional normal value
  • Patient has no clinically significant abnormalities in urinalysis results
  • Patient has acceptable coagulation status as indicated by a PT within normal limits (plus or minus 15%) and PTT within normal limits (plus or minus 15%).
  • Patient has acceptable coagulation status as indicated by a PT within normal limits (plus or minus 15%).
  • Patient has a Karnofsky performance status (KPS) greater or equal to 70 (ECOG PS 0-1).
  • Patient has one or more metastatic tumors measurable by CT scan.
  • Patient has been informed about the nature of study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

  • Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart).
  • Patient uses therapeutic coumadin for a history of pulmonary emboli and deep vein thrombosis (DVT).
  • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Patient has known infection with HIV, hepatitis B, hepatitis C.
  • Patient has undergone major surgery, other than diagnostic surgery (i.e.--) done to obtain a biopsy for diagnosis without removal of an organ), with 4 weeks prior to Day 1 of treatment in this study.
  • Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 3 weeks prior to study entry weeks (6 weeks for nitrosureas or mitomycin C).
  • Patient has a history of allergy or hypersensitivity to the study drug.
  • Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
  • Patient is unwilling or unable to comply with study procedures.
  • Patient is enrolled in any other clinical protocol or investigational trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398086

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Ctr
Birmingham, Alabama, United States
United States, Arizona
Scottsdale Healthcare/Virginia Pipe Cancer Institute
Scottsdale, Arizona, United States, 85258
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 35233
United States, Minnesota
Virigina Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, Texas
South Texas Oncology & Hematology
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
Abraxis BioScience Inc.
Investigators
Principal Investigator: Daniel VonHoff, MD Scottsdale Clinical Research Institute
  More Information

No publications provided

Responsible Party: Abraxis BioScience ( Amanda Johnson, Clinical Trials Manager )
Study ID Numbers: CA040
Study First Received: November 8, 2006
Last Updated: June 8, 2009
ClinicalTrials.gov Identifier: NCT00398086     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:
Metastatic Pancreatic Cancer, Abraxane, Gemcitabine

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009