| Inclusion Criteria: | 1) Pathologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma, AJCC stage IV
2) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =/>20 mm with conventional techniques or as =/>10 mm with spiral CT scan. See Section 11 for the evaluation of measurable disease. Measurable disease must be present outside a previous radiation field or if inside, it must be a new lesion.
3) At least 6 months must have elapsed after completion of adjuvant therapy (if applicable).
4) Age =/>18 years.
5) ECOG Performance Status 0-1 (Karnofsky =/>60%).
6) Patients must have adequate organ and marrow function as defined below: 1) leukocytes =/>3,000 cells/mm^3; 2) absolute neutrophil count =/>1,500 cells/mm^3; 4) platelets =/>100,000 cells/mm^3; 5) total bilirubin <1.5mg/dl; 6) AST(SGOT)/ALT(SGPT) =/<2.5 X institutional upper limit of normal for patients without liver metastasis, =/< 5X institutional upper limit of normal for patients with liver metastasis; 7) creatinine - within normal institutional limits OR creatinine clearance =/>60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
7) Fasting blood glucose =/<160 mg/dl, prior to study enrollment. (For higher values, blood glucose may be controlled by dietary intervention, oral hypoglycemics and/ or insulin prior to enrollment).
8) Women of child-bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation. Acceptable contraception is defined as double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable contraception must be used for 30 days after last dose of study drugs.
9) (Continuation of inclusion criteria # 8) Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
10) Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities.
11) INR <1.5 (or =/<3 if on anticoagulation therapy)
12) Both men and women and members of all races and ethnic groups are eligible for this trial. |