Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

Rationale: Single agent gemcitabine is considered standard care for patients with advanced
pancreatic cancer. However, better treatments offering improved outcomes are needed for
people with this disease. The combination of docetaxel and capecitabine has shown
significant and broad clinical activity in a variety of tumors. Laboratory research on the
combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against
tumor cells. The current study will test this combination in patients. The drug
administration schedule in this study is aimed at maximizing the potential of activation of
capecitabine by both docetaxel and gemcitabine.

Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All
study drugs will be administered through intravenous infusions in three week cycles.
Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on
days 8 through 21. This schedule will be followed by 1 week of rest without administration
of study drugs. Since the primary goal of this study is to identify the maximum tolerated
dose of the study drugs in combination, patients who enroll in the beginning of the study
will receive lower amounts of the study drugs compared to patients who enroll later in the
study. Several tests and exams will be given throughout the study to closely monitor
patients.

Inclusion Criteria:

- adenocarcinoma of the pancreas

- no prior chemo except adjuvant

- ECOG PS 0-1

- peripheral neuropathy
Exclusion Criteria:

- Pregnant/lactating females

- Uncontrolled heart disease, diabetes, psychiatric disorder

- Therapeutic doses of Warfarin