A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer
- 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
- 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
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
- Patient has known infection with human immunodeficiency virus (HIV), hepatitis B,
- 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.