Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)
- 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
- 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.