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A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic Pancreatic Cancer

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Trial Information

A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer

Albumin-bound paclitaxel 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).

This study consisted of a Phase 1 dose escalation phase, a Phase 2 treatment phase and a
24-month follow-up phase.

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 beta-human
chorionic gonadotropin (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-fluorouracil (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

- Absolute neutrophil count (ANC) equal or greater to 1.5 x 10^9/L;

- Platelets equal or greater to 100 x 10^9/L

- Hemoglobin equal or greater to 9 g/dL.

- Patient has the following blood chemistry levels at baseline:

- Aspartate aminotransferase (SGOT), Alanine aminotransferase (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 prothrombin time (PT)
within normal limits (plus or minus 15%) and partial thromboplastin time (PTT) within
normal limits (plus or minus 15%).

- Patient has a Karnofsky performance status (KPS) greater or equal to 70 (Eastern
Cooperative Oncology Group [ECOG] PS 0-1).

- Patient has one or more metastatic tumors measurable by computed tomography (CT)

- 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 human immunodeficiency virus (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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD and DLT of gemcitabine plus ABI-007 in patients with advanced metastatic pancreatic cancer.

Outcome Time Frame:

Enrollment and treatment period 1 year

Safety Issue:


Principal Investigator

Daniel Von Hoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scottsdale Clinical Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

December 2010

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Metastatic Pancreatic Cancer, Abraxane, Gemcitabine
  • Pancreatic Neoplasms



South Texas Oncology & Hematology San Antonio, Texas  78207
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University Baltimore, Maryland  21231
University of Alabama at Birmingham Comprehensive Cancer Ctr Birmingham, Alabama  
Scottsdale Healthcare/Virginia Pipe Cancer Institute Scottsdale, Arizona  85258
Virigina Piper Cancer Institute Minneapolis, Minnesota  55407