A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer

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Brief Title

A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer

Official Title

A Phase II Study of Gemzar, Taxotere, and Xeloda (GTX) for Adjuvant Pancreatic Cancer

Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)

Secondary Outcome

 Time to Death

Condition

Pancreatic Cancer

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Gemcitabine, Docetaxel, Capecitabine GTX
Description:  GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

37

Start Date

September 2006

Completion Date

October 2014

Primary Completion Date

October 2014

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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Paul E Oberstein, MD, , 



Administrative Informations


NCT ID

NCT00882310

Organization ID

AAAB4460


Responsible Party

Sponsor

Study Sponsor

Columbia University


Study Sponsor

Paul E Oberstein, MD, Principal Investigator, Columbia University


Verification Date

June 2016