Study for Inoperable Non-Metastatic Pancreatic CA (Stage IVA) With Neoadjuvant GTX, and Radiation With Gemzar
Condition: Pancreatic Cancer Stage IVA
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine, docetaxel, and capecitabine; Radiation therapy with gemzar
Intervention description: Day 1-14: Capecitabine 1500 mg/m2/day (+/- 2days) Day 4 and 11: Gemcitabine 750 mg/m2/day (+/- 2days) Day 4 and 11: Docetaxel 30 mg/m2/day (+/- 2 days) Two week treatment regimen is followed by one week off, repeated for a total of 3 cycles; Starting on week 12 +/- 5 days radiation therapy will be given in the standard manner over 5 weeks with daily radiation fractions Monday through Friday. Once a week gemcitabine will be given IV over 30 minutes at 250-300 mg/m2
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic cancer; Gemcitabine; Docetaxel; Capecitabine

Summary:

      The purpose of this study is to determine whether an experimental drug combination consisting
      of Gemzar®, Taxotere®, and Xeloda®, (called GTX) when followed by radiation therapy plus
      low-dose Gemzar, is safe and effective in treating advanced pancreatic cancer and to study
      and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of pancreas localized to the pancreas, small
             bowel, stomach and/or encasing the superior mesenteric artery, vein or portal vein.
             (a.k.a. Stage IV A).

          -  No prior chemotherapy for their pancreatic cancer or radiation to the area of the
             tumor.

          -  Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by
             x-ray, physical examination, CT or MRI scans.

          -  Ineligible for other high priority national or institutional studies

          -  Whipple surgery not allowed. Prior surgery is allowed as long as it was not pancreatic
             resection (i.e. Whipple surgery) and the time from surgical recovery is greater than
             three weeks.

          -  Non pregnant females who are not breast feeding with a negative serum 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 to 70 years old

               -  Performance status 0-2 (ECOG). (See Appendix IV)

               -  Peripheral Neuropathy must be < grade 1

               -  Able to tolerate oral medications

               -  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 > 2.5 mg/dl

               -  Total Bilirubin < 5.0 mg/dl

               -  SGOT, SGPT, Alkaline Phosphatase < 4.0 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.

          -  Prior malignancies in last 5 years other than: curatively treated carcinoma in-situ of
             the cervix, non-melanoma skin cancer, prostate or DCIS (ductal carcinoma in-situ)
             previously treated successfully (cancer free)

          -  No serious medical or psychiatric illness preventing informed consent or intensive
             treatment (e.g., serious infection).

          -  Patients known to have HIV will be excluded.

          -  Patients cannot have received any prior investigational agent/therapy, nor will they
             be allowed any investigational agent/therapy while on protocol.