A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere"

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically documented adenocarcinoma of the pancreas

- Recurrent or progressive disease

- Metastatic disease

- Metastatic disease to brain allowed if patient has undergone prior radiotherapy
or is stable, and is not receiving steroids or anticonvulsants

- Must have received 1 prior gemcitabine hydrochloride-based regimen (with or without
radiation therapy)

- Measurable tumor, defined as any lesion ≥ 1 cm by spiral CT scan or ≥ 2 cm by
conventional methods

- Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions,
and positive bone marrow biopsies are not considered measurable or evaluable
disease

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 60 days after
completion of study treatment

- ECOG performance status 0, 1, or 2

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Creatinine ≤ 2.0 mg/dL

- Creatine clearance > 30 mL/min

- Bilirubin normal

- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase
(AP) normal OR AP ≤ 4 times ULN AND SGOT and/or SGPT normal

- No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer,
low-grade low-stage bladder carcinoma being followed off therapy, treated in situ
cervical cancer, or lobular neoplasia of the breast

- No serious uncontrolled medical or psychiatric illness that would render chemotherapy
unsafe

- No clinical AIDS or HIV positivity

- No peripheral neuropathy > grade 1

- No history of severe hypersensitivity reaction to drugs formulated with polysorbate
80

- No prior unanticipated severe reaction to fluoropyrimidine therapy or known
sensitivity to fluorouracil

- No clinically significant cardiac disease (e.g., congestive heart failure,
symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with
medication) or myocardial infarction within the past 12 months

- No lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- At least 3 weeks since prior chemotherapy

- At least 30 days since prior experimental agent

- At least 4 weeks since prior palliative radiotherapy for the primary tumor

- No prior capecitabine or docetaxel

- More than 4 weeks since prior major surgery and recovered

- At least 4 weeks since prior sorivudine or brivudine

- No concurrent sorivudine or brivudine

- No concurrent enrollment in another clinical trial