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

Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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

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.

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

- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to
Taxotere® or other drug formulated with polysorbate 80 will be excluded.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.

Outcome Time Frame:

At days 4, 11, and follow-up.

Safety Issue:


Principal Investigator

Robert L Fine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



Columbia University Medical CenterNew York, New York  10032