A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; Docetaxel; Capecitabine
Intervention description: Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV; Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV; Day 1-14: capecitabine at 1000 mg/m2/day divided into 2 doses given two times a day (BID) by mouth (PO) Maximum dose 2000mg/day divided into BID dosing
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: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pancreatic cancer; Gemzar; Taxotere; Xeloda; GTX

Summary:

      The main purpose of this study will be to evaluate the toxicities as well as the efficacy of
      a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in
      patients with pancreatic cancer, who have undergone complete surgical resection of their
      tumor. During the screening evaluation, subjects will have a physical exam and medical
      history taken by either the PI or a Co investigator. In addition, routine blood tests and
      radiological exams will be performed, to determine eligibility. Following enrollment,
      patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During
      each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over
      the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of
      every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each
      cycle of treatment patients will have a physical examination, as well as routine blood work.
      The first scan will be done prior to initiation of treatment, and the next will be done at
      completion of chemotherapy. A short quality of life questionnaire will also be administered
      prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of pancreas that has been completely resected.
             Patients may be node negative or node-positive, but must have clean margins of
             resection.

          -  Ineligible for other high priority national or institutional studies.

          -  Time from surgical recovery greater than three weeks, but less than six weeks.

          -  All radiological evaluations (which must include either CT scans of the
             chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be
             performed within 4 weeks prior to the start of study therapy.

          -  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.

          -  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 6
             months after completion of treatment. They must understand the risks of infertility
             possibly associated with adjuvant treatment.

          -  Clinical Parameters:

               -  Age ≥ 18 to ≤ 75 years old

               -  Performance status 0-2 (ECOG)

               -  Peripheral Neuropathy must be < grade 1

               -  Able to tolerate oral medications

               -  Absolute Neutrophil Count > 1,500 ul

               -  White Blood Count > 3,000/ul

               -  Platelet count > 100,000/ul

               -  BUN < 1.5 x ULN

               -  Creatinine < 1.5 x ULN

               -  Hemoglobin > 8.0 g/dl

               -  Serum Albumin > 2.5 mg/dl

               -  Total Bilirubin < 3.0 mg/dl

               -  AST ≤4.0 x ULN

               -  ALT ≤4.0 x ULN

               -  Alkaline Phosphatase ≤4.0 x ULN]

               -  CA 19-9 should be normal post surgery. Can still be put on protocol with
                  elevation if clinically significant for inflammation or infection, not cancer

        Exclusion Criteria:

          -  Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.

          -  Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of
             any site in the body.

          -  Serious medical or psychiatric illness preventing informed consent or intensive
             treatment (e.g., serious infection).

          -  Patients with compromised immune systems are at increased risk of toxicity and lethal
             infections when treated with marrow-suppressive therapy. Therefore, HIV-positive
             patients are excluded from the study.

          -  Any prior investigational agent/therapy or any investigational agent/therapy while on
             protocol.

          -  Hypersensitivity: Patients with a history of severe hypersensitivity reaction to
             Taxotere® or other drug formulated with polysorbate 80 will be excluded.