Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of pancreas metastatic to liver and/or lungs or peritoneal surface. (a.k.a. Stage IV B).
• No prior chemotherapy with Gemzar, Xeloda and Taxotere.
• Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.

• The following lesions conventionally are not considered measurable:

  • CNS lesions
  • Blastic or lytic bone lesions (which should be documented and followed)
  • Radiated lesions unless progression after RT is documented
• Ineligible for other high priority national or institutional studies

• Prior radiation and surgery allowed:

  • > 3 weeks since surgery
  • > 4 weeks since RT
• Non pregnant females who are not breast feeding with a negative serum or urine β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.

• Clinical Parameters:

  • Life expectancy > 2 months
  • Age 18 - 70 years old
  • Performance status 0-2 (ECOG)
  • Peripheral Neuropathy must be < grade 1
  • Able to tolerate oral medications

• Required initial laboratory data:

  • Absolute Neutrophil Count > 1,500 μl
  • White Blood Count > 3,000/μl
  • Platelet count > 100,000/μl
  • BUN < 1.5 x normal
  • Creatinine < 1.5 normal
  • Hemoglobin > 8.0 g/dl
  • Serum Albumin > 3 mg/dl
  • Total Bilirubin < 2.0 mg/dl
  • SGOT, SGPT, Alkaline Phosphatase SGOT and SGPT may be up to 3.0 x ULN if Alk Phos < 2.0 x ULN; or Alk Phos may be up to 3.0 x ULN if SGOT and SGPT are < 2.0 x ULN

Exclusion Criteria:

• Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
• Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
• The patient has not had a prior malignancy in last 5 years other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer
• No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
• Patients with brain metastases are excluded.
• Patients known to have HIV will be excluded.