A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The adjuvant treatment of resected pancreatic cancer is currently in flux. Many in the United
      States continue to use 5FU-based chemotherapy with radiation to the pancreatic bed. Some in
      the States, and most investigators in Europe, use a 5FU based chemotherapy-alone approach,
      based on the ESPAC-1 data. Many investigators believe that since gemcitabine is a more active
      drug in the metastatic setting, it should be moved "up front" in the adjuvant treatment of
      pancreatic cancer patients. At Columbia, we offer gemcitabine-based treatments with
      discussions with patients regarding risks, benefits, and limitations in current knowledge. We
      have usually offered radiation to those with positive margins, and chemotherapy alone to
      those without. Based on the early studies using gemcitabine, we believe that this will
      ultimately prove to be a more effective adjuvant drug than 5FU. Some patients have asked for
      GTX in the adjuvant setting as well, prompting the creation of this trial. Because of
      concerns about increased toxicity of this regimen, determination of patient safety will be
      the primary objective of this study, through careful monitoring of adverse events. This trial
      will be a chemotherapy-only study, offered to those with clean margins of resection.

      Taxotere administered "weekly" has activity in a variety of tumor types including breast,
      lung, ovarian and prostate cancer. Patients with advanced breast cancer, including some who
      had previously been treated with paclitaxel or anthracyclines, have responded to the weekly
      administration of Taxotere. The recommended dose of weekly Taxotere is 30-40 mg/m2/week for 6
      out of 8 weeks. The same dose intensity can be achieved on a 3 out of 4 week basis. However,
      this protocol will give drugs 2 out of every 3 weeks, thus dose intensity is less.

      Weekly administration of Taxotere is well tolerated and produces substantially less
      myelosuppression than is observed with standard Taxotere administration every 3 weeks. Acute
      toxicities are uncommon, as is peripheral neuropathy. Prolonged treatment with weekly
      Taxotere, may result in chronic toxicities (including, asthenia (fatigue), anemia, edema,
      excessive lacrimation (epiphora), and onycholysis). Chronic toxicities are most prominent
      when Taxotere is administered on a continuous weekly basis, i.e., without a break, and are
      delayed in onset by providing breaks in treatment (for example, treating 6 out of 8 weeks or
      3 out of 4 weeks); these chronic toxicities occur at a lower cumulative dose when a
      continuous weekly schedule of Taxotere is utilized.

      Premedication with dexamethasone is recommended for all patients receiving weekly Taxotere
      therapy to reduce the incidence and severity of fluid retention as well as the severity of
      hypersensitivity reactions. A variety of dexamethasone schedules have been used in studies
      with weekly Taxotere. Dexamethasone 4 to 8 mg x 3 doses taken orally the night before, the
      morning of, and the evening after Taxotere administration appears to be an effective
      schedule. We have found that a single low dose of 10 mg IV before the Taxotere usually
      prevents anaphylaxis and the pedal edema associated with this drug.
    

Intervention name(s): Gemcitabine; Docetaxel; Capecitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Gemzar; Taxotere; Xeloda
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Gemzar; Taxotere; Xeloda; GTX