Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine, Docetaxel, Capecitabine
Intervention description: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.
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: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Stage IVB

Summary:

      This study is designed to determine whether an investigational drug combination consisting of
      Gemzar®, Taxotere®, and Xeloda®, (called GTX) 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 metastatic to liver and/or lungs
             or peritoneal surface. (a.k.a. Stage IV B).

          -  No prior chemotherapy with Gemzar, Xeloda and Taxotere.

          -  Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by
             x-ray, physical examination, CT or MRI scans.

          -  The following lesions conventionally are not considered measurable:

               -  CNS lesions

               -  Blastic or lytic bone lesions (which should be documented and followed)

               -  Radiated lesions unless progression after RT is documented

          -  Ineligible for other high priority national or institutional studies

          -  Prior radiation and surgery allowed:

               -  > 3 weeks since surgery

               -  > 4 weeks since RT

          -  Non pregnant females who are not breast feeding with a negative serum or urine 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 - 70 years old

               -  Performance status 0-2 (ECOG)

               -  Peripheral Neuropathy must be < grade 1

               -  Able to tolerate oral medications

          -  Required initial laboratory data:

               -  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 > 3 mg/dl

               -  Total Bilirubin < 2.0 mg/dl

               -  SGOT, SGPT, Alkaline Phosphatase SGOT and SGPT may be up to 3.0 x ULN if Alk Phos
                  < 2.0 x ULN; or Alk Phos may be up to 3.0 x ULN if SGOT and SGPT are < 2.0 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.

          -  The patient has not had a prior malignancy in last 5 years other than curatively
             treated carcinoma in-situ of the cervix or non-melanoma skin cancer

          -  No serious medical or psychiatric illness preventing informed consent or intensive
             treatment (e.g., serious infection).

          -  Patients with brain metastases are excluded.

          -  Patients known to have HIV will be excluded.